MatrixORTHOGNATHIC TM Plating System

Transcription

1 Specialized Implants and Instruments for Orthognathic Surgery MatrixORTHOGNATHIC TM Plating System Surgical Technique

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3 TABLE OF CONTENTS INTRODUCTION MatrixORTHOGNATHIC Plating System 2 Features and Benefits 4 MatrixORTHOGNATHIC Plate and Screw Color Coding 6 AO Principles 7 Indications 8 SURGICAL TECHNIQUE LeFort I Fixation 9 Sagittal Split Fixation 12 Sagittal Split Plate with Adjustable Slider (optional) 15 Genioplasty Fixation 20 PRODUCT INFORMATION Implants 22 Instruments 26 Trocar System 29 Modules and Accessories 30 MatrixORTHOGNATHIC Plating System 32 REFERENCE References 36 MR Information The MatrixORTHOGNATHIC Plating System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the MatrixORTHOGNATHIC Plating System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 1

4 MatrixORTHOGNATHIC TM PLATING SYSTEM Specialized implants and instruments for orthognathic surgery INTRODUCTION The aim of surgical fracture treatment is to reconstruct the bony anatomy and restore its function. According to the AO, internal fixation is distinguished by anatomical reduction, stable fixation, preservation of blood supply, and early, active mobilization. 1,2 Plate and screw osteosynthesis has been established and clinically recognized for some time. Keeping the AO philosophy at its core, the Matrix Family is the new plating platform for internal fixation of the craniomaxillofacial skeleton addressing neuro, craniofacial, mandibular, and orthognathic surgery. The Matrix Family is a simple, yet comprehensive, system that offers flexibility and ease of use. Simple All screws work with all plates within each Matrix Family One screwdriver for all screws within each Matrix Family Color-coding by strength for easy identification Effective Low plate-screw profile, where applicable Self-retaining screws/blades Rounded edges on plates Efficient Standardized instrumentation Reduced inventory for hospitals, without compromising clinical solutions 2 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

5 MatrixORTHOGNATHIC Plating System Specialized implants and instruments for orthognathic surgery One screw diameter for all orthognathic indications Reversible L-plates Simple yet comprehensive system for orthognathic surgery MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 3

6 FEATURES AND BENEFITS MatrixORTHOGNATHIC TM Plating System MatrixORTHOGNATHIC is a simple yet comprehensive system that offers precise implants and instruments for orthognathic surgery One standard screw diameter for all orthognathic indications in the midface and mandible Reversible plates allow reduced inventory (where applicable) Etched lines, in 1 mm increments, on implants provide a visual aid for plate bending (where applicable) Color-coding by strength for easy identification MatrixORTHOGNATHIC Screws One standard screw diameter 1.85 mm screws (LeFort I, BSSO, genioplasty) 2.1 mm screws serve as emergency screws Screw designs include Self-drilling (purple) Self-tapping (blue) Emergency (pink) Screw lengths/thread pitch include 4 mm 8 mm / 0.6 mm thread pitch 10 mm 18 mm / 1.0 mm thread pitch Screw recess designed for Self-retention on screwdriver blades Reduced screwdriver blade cam-out Easy screw/blade re-engagement Titanium alloy (Ti-6Al-7Nb) Notes: A 1.55 mm diameter MatrixMIDFACE TM Screw is compatible with the MatrixORTHOGNATHIC Plating System. See page 14 for limitations regarding mandibular applications. 4 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

7 Features and Benefits MatrixORTHOGNATHIC Plates Maxillary Plates L-Plates Reversible design Etched lines, in 1 mm increments, to help determine advancement Bar width increases as bar length increases 0.5 mm thick plates (blue) 0.7 mm thick plates (pink) 0.8 mm thick plates (gold) Pre-bent maxillary plates with 2 mm to 10 mm advancements are 0.8 mm thick (gold) Adaption plates in 0.5 mm (blue), 0.7 mm (pink), and 0.8 mm (gold) thicknesses I-Plates in 0.5 mm (blue) and 0.7 mm (pink) thickness Low profile Commercially pure titanium Note: The Maxillary Module will hold up to two thicknesses of L-plates. 0.5 mm and 0.7 mm thicknesses 0.5 mm and 0.8 mm thicknesses 0.7 mm and 0.8 mm thicknesses Sagittal Split Plates Adjustable slider plate Double-strut design with a low profile Slider allows intraoperative correction of occlusion during plate fixation 0.7 mm thick (pink) Curved and straight BSSO plates 6 mm to 12 mm bar lengths Etched lines, in 1 mm increments, to help determine advancement 1.0 mm thick (gold) Commercially pure titanium Genioplasty Plates Pre-bent chin plates with 4 mm to 10 mm advancements Etched midline for easy centering 0.7 mm thick (pink) Commercially pure titanium MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 5

8 MatrixORTHOGNATHIC PLATE AND SCREW COLOR-CODING The color-coding of implants in the MatrixORTHOGNATHIC Plating System helps to identify the level of strength. The color-coding scale for plates and screws conforms to the Matrix Family strength color-coding scheme. MatrixORTHOGNATHIC Plates n Blue = 0.5 mm thick plates n Pink = 0.7 mm thick plates n Gold = 0.8 mm thick and greater plates Note: The Maxillary Module will hold up to two thicknesses of L-plates. 0.5 mm and 0.7 mm thicknesses 0.5 mm and 0.8 mm thicknesses 0.7 mm and 0.8 mm thicknesses 0.5 mm 0.7 mm 0.8 mm 1.0 mm Comparable to the Orthognathic Modular Fixation System MatrixORTHOGNATHIC Screws n Blue = 1.85 mm diameter self-tapping screws n Purple = 1.85 mm diameter self-drilling screws n Pink = 2.1 mm diameter self-tapping emergency screws Also available: n Silver = 1.55 mm diameter MatrixMIDFACE Self-Drilling Screws n Bronze = 1.55 mm diameter MatrixMIDFACE Self-Tapping Screws 1.3 mm System/ 1.5 mm/2.0 mm System Malleable 1.5 mm System/ 2.0 mm System +2.0 mm System Note: A 1.55 mm diameter MatrixMIDFACE Screw is compatible with the MatrixORTHOGNATHIC Plating System. See page 14 for limitations regarding mandibular applications. MatrixORTHOGNATHIC 1.85 mm Screws Screw diameter Lengths Thread pitch Drill bit diameter 1.85 mm 4 mm 8 mm 0.6 mm 1.4 mm 1.85 mm 10 mm 18 mm 1.0 mm 1.4 mm MatrixORTHOGNATHIC 2.1 mm Screws (emergency) Screw diameter Lengths Thread pitch 2.1 mm 4 mm 8 mm 0.6 mm 2.1 mm 10 mm 18 mm 1.0 mm MatrixMIDFACE 1.55 mm Screws Screw diameter Lengths Thread pitch Drill bit diameter 1.55 mm 4 mm 8 mm 0.6 mm 1.1 mm 1.55 mm 10 mm 12 mm 0.6 mm 1.25 mm 6 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

9 AO PRINCIPLES AO PRINCIPLES In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation. 1,2 In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation 1, 2. 4_Priciples_03.pdf :08 Anatomic reduction Anatomic reduction Fracture reduction and fixation to Fracture reduction and fixation to restore anatomical relationships. restore anatomical relationships. 1 2 Stable fixation Stable fixation Fracture fixation providing absolute Fracture fixation providing absolute or relative stability, as or relative stability, as required by the patient, the injury, and the required by the patient, the injury, personality of the fracture. and the personality of the fracture. Early, active mobilization Early and safe mobilization and and rehabilitation of the injured part part and the patient as a whole. 4 3 Preservation of of blood supply Preservation of of the the blood blood supply supply to to soft tissues and and bone bone by by gentle reduction gentle reduction techniques techniques and and careful handling. 1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer-Verlag; Rüedi TP, Buckley RE, Moran CG. AO Principles of Fracture Management. 1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal 2nd ed. Stuttgart, New York: Thieme; Fixation. 3rd ed. Berlin Heidelberg New York: Springer Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 7

10 INDICATIONS The DePuy Synthes Companies MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and craniofacial skeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible, and chin in adolescents* (greater than 12 to 21 years of age) and adults. Specific Indications for Use: Fractures of the midface and craniofacial skeleton LeFort I osteotomies, sagittal split osteotomies, and genioplasties Orthognathic surgery including reconstructive procedures Warnings: Using an internal fixation system on patients with active or latent infection may cause potential risks which may include construct failure and deterioration of infection. It is at the physician s discretion to evaluate the patient s medical conditions and select a fixation device most appropriate for the individual patient. It is also at the physician s discretion to consider all other necessary treatment methods to effectively manage the infection. Confirm the quality of bone at the selected plate position. Using an internal fixation system on patients with insufficient quantity or quality of bone may cause potential risks which may include device loosening and construct failure. It is at the physician s discretion to evaluate the patient s medical conditions and select a fixation device most appropriate for the individual patient. While the surgeon must make the final decision on implant removal, we recommend that whenever possible and practical for the individual patient, fixation devices should be removed once their service as an aid to healing is accomplished. Implant removal should be followed by adequate postoperative management to avoid refracture. These devices can break during use (when subjected to excessive forces or outside the recommended surgical technique). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the patient, the broken part should be removed. Take care to remove all fragments that are not fixated during the surgery. Steel may elicit an allergic reaction in patients with hypersensitivity to nickel. Instruments and screws may have sharp edges or moving joints that may pinch or tear user s glove or skin. Precautions: Important considerations in achieving quality outcomes for orthognathic surgery in growing patients include accurate diagnosis, proper treatment planning, and appropriate age sequencing of procedures. 3 Physicians should inform their patients about the implant s load restrictions and develop a plan for postoperative behavior and increasing physical loads. Confirm that plate positioning, drill bit, and screw length allow for adequate clearance of the nerves, tooth buds, and/or tooth roots, and the edge of the bone. Confirm the quality of bone at the selected plate position. Predrilling is recommended in fractures with dense bone. Drill rate should never exceed 1800 RPM. Higher rates can result in thermal necrosis of the bone, soft tissue burns, and an oversized hole to be drilled. The adverse effects of an oversized hole include reduced pullout force, increased ease of the screws stripping in bone, and/or suboptimal fixation. Always irrigate during drilling, ensure hole is drilled concentric to plate, and bone debris is removed. Avoid drilling over nerve or tooth roots. Take care while drilling to not damage, entrap, or tear a patient s soft tissue or damage critical structures. Be sure to keep drill clear of loose surgical materials. Handle devices with care and dispose of worn bone cutting instruments in a sharps container. Use the appropriate amount of screws to achieve stable fixation. Stable fixation requires a minimum of 2 screws per segment. Tighten screws in a controlled manner. Applying too much torque to the screws may cause screw/plate deformation, or bone stripping. Surgical implants must never be reused. An explanted metal implant must never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which could lead to breakage. After implant placement is complete, irrigate and apply suction for removal of debris potentially generated during implantation. Check instruments periodically for wear or damage. Replace worn or damaged instruments prior to use. 8 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

11 LEFORT I FIXATION 1 Select plate design Instrument Plate Holder for Reversible Matrix Plates After the osteotomy has been performed and the new position of the maxilla has been established, select the plate shape, quantity, and thickness that best suits the bony anatomy, treatment objective, and quantity and quality of bone. Oblique L-plates, 90 L-plates, and I-plates are recommended for both medial and lateral buttress fixation. Pre-bent maxillary plates are recommended for medial buttress fixation. Anatomic L-plates are recommended for lateral buttress fixation. 2 Select and form the bending template (optional) Instruments Bending Templates for Matrix Anatomic L-plates, 3x3 holes Bending Templates for Matrix Oblique L-plates, 3x3 holes Bending Templates for Matrix 90 L-Plates, x2 holes Select the appropriate shape and length of bending template according to the plate selection and form it to the bony anatomy. Precaution: Bending templates should not be used as an implant or drill guide for surgical planning. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 9

12 LeFort I Fixation 3 Adapt plate to bone Instruments In-plane Plate Bender for Midface Plates Plate Bender for Midface Plates (2 required) Plate Cutter for Midface Plates Cut and contour the plate according to the bending template and the bony anatomy using the Plate Cutters ( ) and the Plate Benders ( , ) respectively. Bend the plate between the holes as necessary. Ensure the plate is passively adapted to the bone. Note: Etched lines, in 1 mm increments, to facilitate bending and placement. Precautions: Damage to developing tooth roots may result in dento-osseous ankylosis and localized dentoalveolar growth impairment. 4 Confirm that plate positioning, drill bit and screw length allow for adequate clearance of nerves, tooth buds and/or tooth roots, and the edge of the bone. Cut the implant adjacent to the screw holes. Take care to protect soft tissue from trimmed edges. Warnings: Do not excessively bend or reverse bend the plates as it may produce internal stresses which may become the focal point for eventual breakage of the implant. Do not alter the bend in the pre-bent plates to achieve more than a 1 mm adjustment in either direction. 11 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

13 LeFort I Fixation 4 Fixate plate to bone Insert proper length 1.85 mm MatrixORTHOGNATHIC Screws to fixate the plate to the underlying bone. If pilot hole is desired, select the appropriate 1.4 mm diameter drill bit length to allow for the adequate clearance of nerves, tooth buds, and/or tooth roots. Engage the screw on the blade, align the blade over the cruciform recess, and slowly rotate it counterclockwise until the blade drops into the recess. Firmly press the blade to fully seat it into the screw. Confirm drill bit length matches screw length. Note: Self-drilling and self-tapping screws are available. Precautions: Confirm that plate positioning, drill bit and screw length allow for adequate clearance of nerves, tooth buds and/or tooth roots, and the edge of the bone. Drill speed rate should never exceed 1,800 rpm, particularly in dense, hard bone. Higher drill speed rates can result in: thermal necrosis of the bone soft tissue burns an oversized hole, which can lead to reduced pullout force, increased ease of the screws stripping in bone, suboptimal fixation, and/or the need for emergency screws. Always irrigate during drilling to avoid thermal damage to the bone. After implant placement is complete, irrigate and apply suction for removal of debris potentially generated during implantation or removal. Avoid drilling over nerve or tooth roots. Take care while drilling to not damage, entrap, or tear a patient s soft tissue or damage critical structures. Be sure to keep drill clear of loose surgical materials. Handle devices with care and dispose of worn bone cutting instruments in an approved sharps container. Use the appropriate amount of screws to achieve stable fixation for fractures. Stable fixation requires a minimum of two screws per bone segment for osteotomies. Warning: Instruments and screws may have sharp edges or moving joints that may pinch or tear user s glove or skin. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 11

14 SAGITTAL SPLIT FIXATION 1 Select plate design Instrument Plate Holder for Reversible Matrix Plates After the sagittal split osteotomy, adjust the occlusion and the joint-bearing segment, and stabilize by intermaxillary fixation. Select a plate shape that best suits the bony anatomy, treatment objective, and the quantity and quality of bone. Straight and curved sagittal split plates are available for monocortical screw placement. The Sagittal Split Plate with Adjustable Slider is also available if intraoperative occlusal adjustments are necessary (see page 15 for technique). Notes: For bicortical screw placement, 1.85 mm diameter MatrixORTHOGNATHIC Screws are available in lengths up to 18 mm (position screws). Predrill using 1.4 mm diameter drill bit without stop. The 10 mm to 18 mm length screws have a larger head diameter for better visibility and force transmission. 2 Select and form the bending template Instruments Bending Template for Matrix Curved Sagittal Split Plate Bending Template for Matrix Straight Sagittal Split Plate Select the appropriate shape and length of bending template according to the plate selection and form it to the bony anatomy. Precaution: Bending templates should not be used as an implant or drill guide for surgical planning. 11 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

15 Sagittal Split Fixation 3 Adapt plate to the bone Instrument Plate Bender for Midface Plates (2 required) Contour the plate according to the bending template and make final adjustments to match the bony anatomy using the Bending pliers ( ). Bend the plate between the holes as necessary. Ensure the plate is passively adapted to the bone. Note: Etched lines, in 1 mm increments, to facilitate bending and placement. Precautions: Damage to developing tooth roots may result in dento-osseous ankylosis and localized dentoalveolar growth impairment. 4 Confirm that plate positioning, drill bit and screw length allow for adequate clearance of nerves, tooth buds and/or tooth roots, and the edge of the bone. Cut the implant adjacent to the screw holes. Take care to protect soft tissue from trimmed edges. Warning: Do not excessively bend or reverse bend the plates, which can produce internal stress which may become the focal point for eventual breakage of the implant. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 11

16 Sagittal Split Fixation 4 Fixate plate to the bone Select the appropriate 1.4 mm diameter drill bit length to allow for the adequate clearance of nerves, tooth buds, and/or tooth roots. Insert the appropriate length 1.85 mm MatrixORTHOGNATHIC Screws to fixate the plate to the underlying bone. Engage the screw on the blade, align the blade over the cruciform recess, and slowly rotate it counterclockwise until the blade drops into the recess. Firmly press the blade to fully seat it into the screw. Confirm drill bit length matches screw length. Precautions: The 1.55 diameter MatrixMIDFACE Screw is not recommended for sagittal split fixation. Confirm that plate positioning, drill bit, and screw length allow for adequate clearance of nerves, tooth buds and/or tooth roots, and the edge of the bone. Drill speed rate should never exceed 1,800 rpm, particularly in dense, hard bone. Higher drill speed rates can result in: thermal necrosis of the bone soft tissue burns an oversized hole, which can lead to reduced pullout force, increased ease of the screws stripping in bone, suboptimal fixation, and/or the need for emergency screws Always irrigate during drilling to avoid thermal damage to the bone. After implant placement is complete, irrigate, and apply suction for removal of debris potentially generated during implantation or removal. Avoid drilling over nerve or tooth roots. Take care while drilling to not damage, entrap, or tear a patient s soft tissue or damage critical structures. Be sure to keep drill clear of loose surgical materials. Handle devices with care and dispose of worn bone cutting instruments in an approved sharps container. Use the appropriate amount of screws to achieve stable fixation for fractures. Stable fixation requires a minimum of two screws per bone segment for osteotomies. Warning: Instruments and screws may have sharp edges or moving joints that may pinch or tear user s glove or skin DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

17 SAGITTAL SPLIT PLATE WITH ADJUSTABLE SLIDER (optional) 1 Select plate design Instrument Plate Holder for Reversible Matrix Plates After the sagittal split osteotomy, adjust the occlusion and the joint-bearing segment, and stabilize by intermaxillary fixation. Select the appropriate Sagittal Split Plate with Adjustable Slider that best suits the bony anatomy, treatment objective, and the quantity and quality of bone. 2 Select and form the bending template (optional) Instruments Bending Template for Sagittal Split Plate, with adjustable slider Select the appropriate length of bending template according to the plate selection and form it to the bony anatomy. Precaution: Bending templates are not to be used as an implant or drill guide for surgical planning. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 11

18 Sagittal Split Plate with Adjustable Slider (optional) 3 Adapt plate to the bone Instrument Plate Bender for Midface Plates (2 required) Contour the plate according to the bending template and bony anatomy using the bending pliers ( ). Bend the plate between the holes as necessary. Ensure the plate is passively adapted to the bone. Notes: Etched lines, in 1 mm increments, provide a visual guide for bending. Since the slider will not slide in the contoured section, the plate should be contoured as far proximally as possible. Precautions: Damage to developing tooth roots may result in dento-osseous ankylosis and localized dentoalveolar growth impairment. 4 Confirm that plate positioning, drill bit and screw length allow for adequate clearance of nerves, tooth buds and/or tooth roots, and the edge of the bone. Warning: Do not excessively bend or reverse bend the plates as it may produce internal stresses which may become the focal point for eventual breakage of the implant. 11 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

19 Sagittal Split Plate with Adjustable Slider (optional) 4 Primary plate fixation Select the appropriate 1.4 mm drill bit length to allow for the adequate clearance of nerves, tooth buds, and/or tooth roots. Fixate the Sagittal Split Plate with Adjustable Slider to the bone by drilling and inserting the proper length 1.85 mm MatrixORTHOGNATHIC Screws in the specified sequence as shown (1 3) (Figure 1). Screws should be placed monocortically. Engage the screw on the blade, align the blade over the cruciform recess, and slowly rotate it counterclockwise until the blade drops into the recess. Firmly press the blade to fully seat it into the screw. Precautions: Confirm that plate positioning, drill bit and screw length allow for adequate clearance of nerves, tooth buds and/or tooth roots, and the edge of the bone. Drill speed rate should never exceed 1,800 rpm, particularly in dense, hard bone. Higher drill speed rates can result in: thermal necrosis of the bone soft tissue burns an oversized hole, which can lead to reduced pullout force, increased ease of the screws stripping in bone, suboptimal fixation, and/or the need for emergency screws. Always irrigate during drilling to avoid thermal damage to the bone. After implant placement is complete, irrigate and apply suction for removal of debris potentially generated during implantation or removal. Avoid drilling over nerve or tooth roots. Take care while drilling to not damage, entrap, or tear a patient s soft tissue or damage critical structures. The 1.5 mm MatrixMIDFACE Screw is not recommended for sagittal split fixation. The 2.1 mm self-tapping screw is not recommended for slider fixation. Be sure to keep drill clear of loose surgical materials. Figure Handle devices with care and dispose of worn bone cutting instruments in an approved sharps container. Use the appropriate amount of screws to achieve stable fixation for fractures. Stable fixation requires a minimum of two screws per bone segment for osteotomies. Warning: Instruments and screws may have sharp edges or moving joints that may pinch or tear user s glove or skin. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 11

20 Sagittal Split Plate with Adjustable Slider (optional) 5 Operative correction of occlusion Release the intermaxillary fixation and inspect the occlusion. If the occlusion needs adjustment, loosen the screw (3) in the slider plate (Figure 2). The distal bone segment can now be shifted horizontally and vertically until the occlusion has been corrected. Retighten the screw (3) in the slider. The process can be repeated if necessary. Precaution: Ensure the desired condylar positioning has been achieved. 3 Figure 2 11 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

21 Sagittal Split Plate with Adjustable Slider (optional) 6 Final plate fixation Using the 1.4 mm diameter drill bit to drill, insert the remaining proper length 1.85 mm MatrixORTHOGNATHIC Screws in holes (4) and (5) (Figure 3). Engage the screw on the blade, align the blade over the cruciform recess, and slowly rotate it counterclockwise until the blade drops into the recess. Firmly press the blade to fully seat it into the screw. Remove the screw (3) and the slider plate component. Ensure fixation of the mandible is adequate to withstand the sagittal forces Warnings: The slider is strictly for intraoperative use only; do not leave in-situ. Previous changes in tempromandibular joint may affect surgical outcome. Instruments and screws may have sharp edges or moving joints that may pinch or tear user s glove or skin. Precautions: Drill speed rate should never exceed 1,800 rpm, particularly in dense, hard bone. Higher drill speed rates can result in: thermal necrosis of the bone soft tissue burns an oversized hole, which can lead to reduced pullout force, increased ease of the screws stripping in bone, suboptimal fixation, and/or the need for emergency screws. Always irrigate during drilling to avoid thermal damage to the bone. After implant placement is complete, irrigate and apply suction for removal of debris potentially generated during implantation or removal. Avoid drilling over nerve or tooth roots. Take care while drilling to not damage, entrap, or tear a patient s soft tissue or damage critical structures. Be sure to keep drill clear of loose surgical materials. Figure 3 Handle devices with care and dispose of worn bone cutting instruments in an approved sharps container. Use the appropriate amount of screws to achieve stable fixation for fractures. Stable fixation requires a minimum of two screws per bone segment for osteotomies. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 11

22 GENIOPLASTY FIXATION 1 Select plate design Instrument Plate Holder for Reversible Matrix Plates After the osteotomy has been performed and the advancement of the distal segment has been established, select the plate design that best suits the bony anatomy, treatment objective, and the quantity and quality of the bone. The chin plates are available in 4 mm to 10 mm offsets. 2 Adapt plate to bone Instrument Plate Bender for Midface Plates (2 required) Contour the selected plate to the bone, using the plate benders. Bend the plate between the holes as necessary. Ensure the plate is passively adapted to the bone. Note: The etched centerline helps with plate alignment on the bone. Precautions: Damage to developing tooth roots may result in dento-osseous ankylosis and localized dentoalveolar growth impairment. 4 Confirm that plate positioning, drill bit and screw length allow for adequate clearance of nerves, tooth buds and/or tooth roots, and the edge of the bone. Warnings: Do not excessively bend or reverse bend the plate, which can produce internal stresses which may become the focal point for eventual breakage of the implant. Do not alter the bend in the pre-bent plates to achieve more than a 1 mm adjustment in either direction. 22 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

23 Genioplasty Fixation 3 Fix plate to bone Use a 1.4 mm drill bit to drill, and insert the proper length 1.85 mm diameter MatrixORTHOGNATHIC Screws to fixate the plate to the bone. Engage the screw on the blade, align the blade over the cruciform recess, and slowly rotate it counterclockwise until the blade drops into the recess. Firmly press the blade to fully seat it into the screw. Precautions: Confirm that plate positioning, drill bit, and screw length allow for adequate clearance of nerves, tooth buds and/or tooth roots, and the edge of the bone. Drill speed rate should never exceed 1,800 rpm, particularly in dense, hard bone. Higher drill speed rates can result in: thermal necrosis of the bone soft tissue burns an oversized hole, which can lead to reduced pullout force, increased ease of the screws stripping in bone, suboptimal fixation, and/or the need for emergency screws. Always irrigate during drilling to avoid thermal damage to the bone. After implant placement is complete, irrigate, and apply suction for removal of debris potentially generated during implantation or removal. Avoid drilling over nerve or tooth roots. Take care while drilling to not damage, entrap, or tear a patient s soft tissue or damage critical structures. The 1.5 mm MatrixMIDFACE Screw is not recommended for genioplasty fixation. Be sure to keep drill clear of loose surgical materials. Handle devices with care and dispose of worn bone cutting instruments in an approved sharps container. Use the appropriate amount of screws to achieve stable fixation for fractures. Stable fixation requires a minimum of two screws per bone segment for osteotomies. Warning: Instruments and screws may have sharp edges or moving joints that may pinch or tear user s glove or skin. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 22

24 IMPLANTS Titanium MatrixORTHOGNATHIC Screws 1.85 mm Self-tapping Screws (5/pkg.) Length (mm) , coarse pitch , coarse pitch , coarse pitch , coarse pitch , coarse pitch 1.85 mm Self-drilling Screws (5/pkg.) Length (mm) mm Emergency Screws, self-tapping (5/pkg.) Length (mm) , coarse pitch , coarse pitch , coarse pitch , coarse pitch , coarse pitch Note: Screws are made of titanium alloy (Ti-6Al-7Nb). Plates are made of commercially pure titanium. For single-pack screws, change.05 to.01 at end of product number. 22 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

25 Implants Titanium MatrixORTHOGNATHIC Plates 90 L-Plates, 2 x 2 holes, reversible Type Bar length (mm) Thickness (mm) short medium long short medium long short medium long Oblique L-Plates, 3 x 3 holes, reversible Type Bar length (mm) Thickness (mm) short medium long short medium long short medium long Oblique L-Plates, 3 x 4 holes, reversible Type Bar length (mm) Thickness (mm) short medium short medium MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 22

26 Implants Anatomic L-Plates, 3 x 3 holes, reversible Type Bar length (mm) Thickness (mm) short medium long short medium long short medium long I-Plates, 4 holes Thickness (mm) Pre-bent Maxillary Plates, 0.8 mm thick Advancement (mm) left right left right left right left right left right 10 Adaption Plates, 20 holes Thickness (mm) mm mm mm 22 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

27 Implants Curved Sagittal Split Plates, 6 holes, 1.0 mm thick Bar (mm) Straight Sagittal Split Plates, 4 holes, 1.0 mm thick Bar (mm) Sagittal Split Plates with Adjustable Slider, 4 holes, 0.7 mm thick Length (mm) Chin Plates with Double Bend, 5 holes, 0.7 mm thick Offset (mm) MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 22

28 SELECTED MatrixORTHOGNATHIC INSTRUMENTS Mini Plate Holder, long In-Plane Plate Bender Plate Bender for Midface Plates (2 required) Plate Cutter for Midface Plates 22 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

29 Selected MatrixORTHOGNATHIC Instruments MatrixMIDFACE Screwdriver Blades, self-retaining, hex coupling mm mm mm Plate Holder for Reversible Matrix Plates Matrix 1.4 mm Drill Bits, J-latch mm length, 4 mm stop mm length, 6 mm stop mm length, 8 mm stop mm length, 12 mm stop mm length mm length mm length MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 22

30 Selected MatrixORTHOGNATHIC Instruments Screwdriver Handles, with hex coupling Small Medium Large Ratcheting Screwdriver Handle Screwdriver Handle with hex coupling, locking, medium 22 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

31 TROCAR SYSTEM MatrixORTHOGNATHIC Trocar Drill Guide for Matrix 1.4 mm Drill Bit, J-latch Calibrated for Universal Trocar Handle mm Cannula and Obturator Malleable C-Retractor mm Cheek Retractor Blade mm Cheek Retractor Ring MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 22

32 MODULES AND ACCESSORIES Maxillary Module Assembly Maxillary Generic Module (with lid) Maxillary Module Lid Screw, Drill Bit, Blade Insert, with Recessed Holes * Screw, Drill Bit, Blade Insert, with no Recessed Holes Pre-bent Plate Insert Anatomic L and Adaption Plate Insert and Oblique L-Plate Insert *Also available. 33 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

33 Modules and Accessories Mandible Module Assembly Mandible Generic Module (with lid) Mandible Module Lid Sagittal Split Plate Insert Screw, Drill Bit, Blade Insert, with Recessed Holes * Screw, Drill Bit, Blade Insert, with no Recessed Holes Chin Plate Insert Instrument Tray Instrument Tray Trocar Instrument Insert *Also available. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 33

34 MatrixORTHOGNATHIC PLATING SYSTEM Set MatrixORTHOGNATHIC Plating System Set Graphic Case and Modules Graphic Case (with lid) Graphic Case Lid Mandible Generic Module (with lid) Mandible Module Lid Sagittal Split Plate Insert Screw, Drill Bit, Blade Insert with Recessed Holes Maxillary Generic Module (with lid) Maxillary Module Lid Chin Plate Insert Pre-bent Plate Insert and Oblique L-Plate Insert Anatomic L and Adaption Plate Insert Instrument Tray Trocar Instrument Insert Label Sheets and Screw Length Markers Label Sheets For Maxillary Module For Mandible Module For Instrument Tray For Screw Length Color Chart For MatrixMIDFACE and MatrixORTHOGNATHIC Strength Gradients Screw Length Markers, for self-drilling screws (1/pkg.) W 4 mm W 5 mm W 6 mm W 8 mm Screw Length Markers, for self-tapping screws (10/pkg.) mm mm mm mm mm mm mm mm mm Also Available Screw, Drill Bit, Blade Insert, with no Recessed Holes 33 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

35 MatrixORTHOGNATHIC Plating System Titanium MatrixORTHOGNATHIC Screws 1.85 mm Screws, self-tapping (5/pkg.) mm mm mm mm mm, coarse pitch mm, coarse pitch mm, coarse pitch mm, coarse pitch mm, coarse pitch 1.85 mm Screws, self-drilling (5/pkg.) mm mm mm mm 2.1 mm Screws, self-tapping (5/pkg.) mm mm mm mm mm, coarse pitch mm, coarse pitch mm, coarse pitch mm, coarse pitch mm, coarse pitch Titanium MatrixORTHOGNATHIC Plates 90 L-Plates, 2 x 2 holes, reversible Short, 0.5 mm thick Medium, 0.5 mm thick Long, 0.5 mm thick Short, 0.7 mm thick Medium, 0.7 mm thick Long, 0.7 mm thick Short, 0.8 mm thick Medium, 0.8 mm thick Long, 0.8 mm thick Oblique L-Plates, 3 x 3 holes, reversible Short, 0.5 mm thick Medium, 0.5 mm thick Long, 0.5 mm thick Short, 0.7 mm thick Medium, 0.7 mm thick Long, 0.7 mm thick Short, 0.8 mm thick Medium, 0.8 mm thick Long, 0.8 mm thick Oblique L-Plates, 3 x 4 holes, reversible Short, 0.5 mm thick Medium, 0.5 mm thick Short, 0.7 mm thick Medium, 0.7 mm thick Anatomic L-Plates, 3 x 3 holes, reversible Short, 0.5 mm thick Medium, 0.5 mm thick Long, 0.5 mm thick Short, 0.7 mm thick Medium, 0.7 mm thick Long, 0.7 mm thick Short, 0.8 mm thick Medium, 0.8 mm thick Long, 0.8 mm thick I-Plates, 4 holes mm thick mm thick Note: For single-pack screws, change.05 to.01 at end of product number. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 33

36 MatrixORTHOGNATHIC Plating System Pre-bent Maxillary Plates, 0.8 mm thick mm advancement, left mm advancement, right mm advancement, left mm advancement, right mm advancement, left mm advancement, right mm advancement, left mm advancement, right mm advancement, left mm advancement, right Curved Sagittal Split Plates, 6 holes, 1.0 mm thick mm bar mm bar mm bar mm bar Straight Sagittal Split Plates, 4 holes, 1.0 mm thick mm bar mm bar mm bar mm bar Sagittal Split Plates with Adjustable Slider, 4 holes, 0.7 mm thick mm mm Chin Plates with Double Bend, 5 holes, 0.7 mm thick mm offset mm offset mm offset mm offset Titanium MatrixMIDFACE Plates Adaption Plates, 20 holes mm thick mm thick mm thick Instruments Screwdriver Handles with hex coupling Small Medium Large Ratcheting Screwdriver Handle, hex coupling Locking, medium MatrixMIDFACE Screwdriver Blades, self-retaining, hex coupling mm mm mm Mini Plate Holder, long Plate Holder for Reversible Matrix Plates In-Plane Bender Plate Bender (2 required) Plate Cutter Plate Holding Forceps Matrix 1.4 mm Drill Bits, Stryker J-latch mm, 4 mm stop mm, 6 mm stop mm, 8 mm stop mm, 12 mm stop mm length mm length mm length Trocar System mm Calibrated Drill Bit, J-latch Universal Trocar Handle mm Cannula and Obturator MatrixORTHOGNATHIC Trocar Drill Guide mm Cheek Retractor Blade mm Cheek Retractor Ring Malleable C-Retractor MatrixMANDIBLE Depth Gauge 33 DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

37 MatrixORTHOGNATHIC Plating System Also Available Matrix 1.4 mm Drill Bits Universal Trocar Drill Bit, quick coupling, Calibrated, (8 18 mm), 100 mm Basic Trocar Drill Bit, J-latch, calibrated, 125 mm Bending Templates, 0.5 mm thick* For Adaption Plate, 20 holes For Reversible Anatomic L-Plate, short For Reversible Anatomic L-Plate, medium For Reversible Anatomic L-Plate, long For Reversible Oblique L-Plate, short For Reversible Oblique L-Plate, medium For Reversible Oblique L-Plate, long For Reversible 90 L-Plate, short For Reversible 90 L-Plate, medium For Reversible 90 L-Plate, long For Curved Sagittal Split Plate, 6 mm bar For Curved Sagittal Split Plate, 8 mm bar For Curved Sagittal Split Plate, 10 mm bar For Curved Sagittal Split Plate, 12 mm bar For Straight Sagittal Split Plate, 6 mm bar For Straight Sagittal Split Plate, 8 mm bar For Straight Sagittal Split Plate, 10 mm bar For Straight Sagittal Split Plate, 12 mm bar For Sagittal Split Plate with Slider, 33 mm For Sagittal Split Plate with Slider, 40 mm Titanium MatrixMIDFACE Screws 1.55 mm Titanium MatrixMIDFACE Screws, self-tapping (5/pkg.) mm mm mm mm mm mm mm mm mm 1.55 mm Titanium MatrixMIDFACE Screws, self-drilling (5/pkg.) mm mm mm mm 1.5 mm Drill Bits, Stryker J-latch mm length, 4 mm stop mm length, 6 mm stop mm length, 8 mm stop mm length, 12 mm stop mm length, 60 mm stop mm length Matrix 1.4 mm Drill Bits for 90 Screwdriver mm length, 6 mm stop mm length, 8 mm stop mm length, 12 mm stop mm length, 14 mm stop mm length, 16 mm stop mm length, 18 mm stop Mini Module for MatrixORTHOGNATHIC, for 90 Screwdriver *Bending templates cannot be used as drill guides. For detailed cleaning and sterilization instructions, please refer to or sterilization instructions, if provided. MatrixORTHOGNATHIC TM Plating System Surgical Technique DePuy Synthes 33

38 REFERENCES 1. Müller, ME, M. Allgöwer, R. Schneider, H. Willenegger. Manual of Internal Fixation, 3rd edition. Berlin: Springer-Verlag Rüedi, TP, RE. Buckley, CG. Moren. AO Principles of Fracture Management. 2nd expanded ed Stuttgart, New York: Thieme. 3. Schendel SA, Wolford LM, Epker BN. Surgical advancement of the mandible in growing children: Treatment results in twelve patients. J Oral Surg. 1976; Wolford LM, Karras SC, Mehra P. Considerations for orthognathic surgery during growth, part 2: maxillary deformities. Am J Orthod Dentofacial Orthop. 2001;119: DePuy Synthes MatrixORTHOGNATHIC TM Plating System Surgical Technique

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40 Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information. CAUTION: Federal Law restricts these devices to sale by or on the order of a physician. Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Not all products may currently be available in all markets. Manufactured or distributed by: Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA Synthes USA, LLC 1101 Synthes Avenue Monument, CO To order (USA): To order (Canada): Note: For recognized manufacturer, refer to the product label. DePuy Synthes All rights reserved. DSUS/CMF/1114/0249(2) 3/18 DV