Low Profile Neuro Plating System. Surgical Technique

Low Profile Neuro Plating System Surgical Technique

TABLE OF CONTENTS INTRODUCTION Low Profile Neuro Plating System 2 SURGICAL TECHNIQUE Technique 5 PRODUCT INFORMATION Low Profile Neuro Plates 10 Low Profile Neuro Mesh 12 Instruments 13 Modules and Trays 15 MR Information The Low Profile Neuro 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 Low Profile Neuro Plating System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Low Profile Neuro Plating System Surgical Technique DePuy Synthes 1

LOW PROFILE NEURO PLATING SYSTEM 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 precise reduction, stable fixation, preservation of blood supply, and early mobilization. 1 Plate and screw osteosynthesis has been established and clinically recognized for some time. The Low Profile Neuro Plating System is a cranial closure system that features low plate/screw profile, wide variety of implants, and modular storage options. Warnings: Not intended for use in patients who are not yet skeletally mature. Resorbable fixation products should be considered as an alternative. 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 individual patient, the broken part should be removed. Be aware that implants are not as strong as native bone. Implants subjected to substantial loads may fail. Precaution: 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. 1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991. 2 DePuy Synthes Low Profile Neuro Plating System Surgical Technique

LOW PROFILE NEURO PLATING SYSTEM Indications DePuy Synthes Low Profile Neuro 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 and chin. Features x Low plate-and-screw profile for decreased palpability x Self-drilling,* self-retaining screws, with modified cruciform recess, facilitate rapid replacement of bone flap x Wide variety of low-profile plates to repair the most common types of bony defects and fractures x Modular storage options to meet specific surgeon needs Low-profile construct x Variety of plates to meet specific patient and surgeon needs 0.60 mm 0.75 mm 0.90 mm Low Profile DePuy Synthes DePuy Synthes Neuro 1.3 mm 1.5 mm Low-profile mesh x Available in a wide variety of shapes and sizes x Rigid (0.6 mm thick, silver) and malleable (0.4 mm thick, blue) mesh x Design allows screw placement through either side of mesh x Available nonsterile or sterile-packed *Self-tapping screws are also available. Data on file. Low Profle Neuro Plating System Surgical Technique DePuy Synthes 3

Low Profile Neuro Plating System Self-drilling screws x Screws are self-drilling* for easy, one-step insertion x Made from titanium alloy (Ti-6Al-7Nb) x Modified cruciform recess provides: High-torque capacity Optimal screw retention for quick and easy insertion of screws Low-profile rigid fixation x Available in 3 mm 6 mm lengths Hex coupling screwdriver handles x Available in 3 sizes, including a large ergonomic handle x Hexagonal coupling for easy blade insertion and removal 311.005 311.006 311.007 *Self-tapping screws are also available. Mechanical test data on file at DePuy Synthes. Mechanical test results are not necessarily indicative of clinical performance. 4 DePuy Synthes Low Profile Neuro Plating System Surgical Technique

SURGICAL TECHNIQUE 1 Select implant Select the appropriate implants depending on use. The Low Profile Neuro Plating System contains a wide variety of plates, burr hole covers, mesh, and screws. Precaution: When using plates, ensure countersink holes are facing upward. 2 Size implant (if required) Instrument 391.952 Mesh Cutter Implants may be cut and sized to match the patient anatomy. Replace worn or damaged cutting instruments if the cutting function is not adequate. Precautions: Take care to protect soft tissue from trimmed edges. Replace worn or damaged cutting instruments if the cutting function is not adequate. Cut the implant immediately adjacent to the screw holes. Low Profile Neuro Plating System Surgical Technique DePuy Synthes 5

Surgical Technique 3 Contour implant (if required) Instrument 329.14 Universal Bending Pliers (two required) The implant can be contoured to match the patient s anatomy. Precaution: Excessive and repetitive bending of the implant increases the risk of implant breakage. 4 Position implant Instrument 348.98 Plate Holding Forceps, Locking Position the implant on the desired location using the appropriate plate holder. 1 DePuy Synthes Low Profle Neuro Plating System Surgical Technique

Surgical Technique 5 Pre-drill screw holes (optional) Instruments 316.624 1.1 mm Drill Bit, hex coupling, 4 mm stop, 52 mm 316.626 1.1 mm Drill Bit, hex coupling, 6 mm stop, 52 mm 317.14 1.1 mm Drill Bit, Stryker J-Latch coupling, 4 mm stop, 44.5 mm 317.16 1.1 mm Drill Bit, Stryker J-Latch coupling, 6 mm stop, 44.5 mm Precautions: DePuy Synthes recommends pre-drilling in dense bone when using 5 mm or 6 mm screws. Drill rate should never exceed 1,800 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 screws stripping in bone, and/or suboptimal fixation. Irrigate during drilling to avoid thermal damage to the bone. Handle devices with care and dispose worn bone cutting instruments in a sharps container. Use only a 1.3 mm drill bit for pre-drilling. 6 Secure implant Instruments 313.931 Low Profile Neuro Cruciform Screwdriver Blade, hex coupling, self-retaining, short 313.932 Low Profile Neuro Cruciform Screwdriver Blade, hex coupling, self-retaining, medium 311.005 Screwdriver Handle, hex coupling, small 311.006 Screwdriver Handle, hex coupling, medium To load the screw onto the blade, place the blade perpendicular to the screw in the module and fully insert the blade into the screw recess. The screw should be securely attached to the blade. 311.007 Screwdriver Handle, hex coupling, large Low Profle Neuro Plating System Surgical Technique DePuy Synthes 1

Surgical Technique For optimal plate/screw profile, insert the screw perpendicular to the plate/bone in the appropriate plate hole. If the screw does not obtain purchase, replace it with a blue Low Profile Neuro emergency screw of the same length. Screwdriver shafts are self-retaining. Replace screwdriver shafts if they are worn or damaged, or if retention is not adequate. Precautions: Fully engage the shaft perpendicular to the screw head. Place the 1.6 mm self-drilling screw perpendicular to the bone at the appropriate plate hole. Take care not to over tighten the screw. In order to determine the appropriate amount of fixation for stability, the surgeon should consider the size and shape of the fracture or osteotomy. DePuy Synthes recommends at least three plates when repairing osteotomies. Additional fixation is recommended to ensure stability of large fractures and osteotomies. When using mesh for larger defects, additional screws for fixation are recommended. After implant placement is complete, discard any fragments or modified parts in an approved sharps container. Irrigate and apply suction for removal of debris potentially generated during implantation. 8 DePuy Synthes Low Profile Neuro Plating System Surgical Technique

Surgical Technique Notes: Secure the implants to the bone flap before positioning the bone flap on the patient. 1 1. Secure the desired plates to bone flap. 2. Position the bone flap. 3. Secure the plates to the skull. In order to determine the appropriate amount of fixation for stability, the surgeon should consider the size and shape of a fracture or osteotomy. Precautions: DePuy Synthes recommends at least three plates when repairing osteotomies. Additional fixation is recommended to ensure stability of large fractures and osteotomies. When using mesh for larger defects, additional screws for fixation are recommended. After implant placement is complete, discard any fragments or modified parts in an approved sharps container. Irrigate and apply suction for removal of debris potentially generated during implantation. 2 3 Low Profile Neuro Plating System Surgical Technique DePuy Synthes 9

LOW PROFILE NEURO PLATES 421.525 Titanium Low Profile Neuro Burr Hole Cover, 12 mm diameter Also available in 15 mm, 17 mm, and 24 mm, see page 18 421.554 Titanium Low Profile Neuro Burr Hole Cover, for shunt, 17 mm diameter Also available in 15 mm, see page 18 421.502 Titanium Low Profile Neuro Straight Plate, 2 holes, 12 mm Also available in 2 holes, 9 mm, see page 18 421.504 Titanium Low Profile Neuro Straight Plate, 4 holes 421.510 Titanium Low Profile Neuro X-Plate, 4 holes 421.511 Titanium Low Profile Neuro Box Plate, 14 mm x 14 mm Also available in 10 mm x 16 mm and 16 mm x 16 mm, see page 18 10 DePuy Synthes Low Profle Neuro Plating System Surgical Technique

Low Profile Neuro Plates 421.515 Titanium Low Profile Neuro Y-Plate, 5 holes 421.516 Titanium Low Profile Neuro Double Y-Plate, 6 holes, 18 mm Also available in 6 holes, 21 mm, see page 18 421.519 Titanium Low Profile Neuro Adaption Plate, 7 holes Also available in 5 holes and 20 holes, see page 18 421.523 Titanium Low Profile Neuro Strut Plate, 2 x 4 holes Also available in 2 x 3 holes, see page 18 421.501 Titanium Low Profile Neuro Contourable Strut Plate, 8 holes Low Profle Neuro Plating System Surgical Technique DePuy Synthes 11

LOW PROFILE NEURO MESH 421.500 Titanium Low Profile Neuro Temporal Mesh Plate, malleable, medium 421.540 Titanium Low Profile Neuro Contourable Mesh, 30 mm diameter, blue, 0.4 mm malleable Also available in other shapes and sizes, see page 18 421.543 Titanium Low Profile Neuro Contourable Mesh, 30 mm diameter, silver, 0.6 mm rigid Also available in other shapes and sizes, see page 18 421.546 Titanium Low Profile Neuro Contourable Mesh, mastoid, large, blue, 0.4 mm, malleable Also available in medium, see page 18 12 DePuy Synthes Low Profle Neuro Plating System Surgical Technique

INSTRUMENTS 313.931 Low Profile Neuro Cruciform Screwdriver Blade, self-retaining, hex coupling, short 313.932 Low Profile Neuro Cruciform Screwdriver Blade, self-retaining, hex coupling, medium 329.14 Universal Bending Pliers (two required) 391.952 Mesh Cutter Low Profle Neuro Plating System Surgical Technique DePuy Synthes 13

Instruments 348.98 Plate Holding Forceps, locking 311.005 Screwdriver Handle with hex coupling, small 311.006 Screwdriver Handle with hex coupling, medium 311.007 Screwdriver Handle with hex coupling, large 316.624 1.1 mm Drill Bit, hex coupling, 4 mm stop, 52 mm 316.626 1.1 mm Drill Bit, hex coupling, 6 mm stop, 52 mm 317.14 1.1 mm Drill Bit, Stryker J-Latch coupling, 4 mm stop, 44.5 mm 317.16 1.1 mm Drill Bit, Stryker J-Latch coupling, 6 mm stop, 44.5 mm 14 DePuy Synthes Low Profle Neuro Plating System Surgical Technique

MODULES AND TRAYS 304.634 Low Profile Neuro Compact Module 304.674 Low Profile Neuro Standard Module For detailed cleaning and sterilization instructions, please refer to www.synthes.com/cleaning-sterilization or sterilization instructions, if provided. Low Profile Neuro Plating System Surgical Technique DePuy Synthes 11

Modules and Trays 304.760 Universal Instrument Tray, large, deep 304.761* Neuro Instrument Tray Lid, large 304.762 Neuro Insert Tray, for instruments 304.771 Universal Instrument Tray, extra large, deep 304.772* Neuro Instrument Tray Lid, extra large 304.773 Neuro Insert Tray, for cranial clamps 304.762 Neuro Insert Tray, for instruments 304.760 Universal Instrument Tray, large, deep 304.761* Neuro Instrument Tray Lid, large 304.774 Neuro Insert Tray, for Battery Powered Screwdriver *Lids not shown. 11 DePuy Synthes Low Profile Neuro Plating System Surgical Technique

LOW PROFILE NEURO SYSTEM Set, Modules, and Trays 145.827 Titanium Low Profile Neuro System 304.634 Low Profile Neuro Compact Module 304.634.40 Label Sheet, for Low Profile Neuro Module 304.674 Low Profile Neuro Standard Module 304.760 Universal Instrument Tray, large, deep 304.761 Neuro Instrument Tray Lid, large 304.762 Neuro Insert Tray, for instruments 304.771 Universal Instrument Tray, extra large, deep 304.772 Neuro Instrument Tray Lid, extra large 304.773 Neuro Insert Tray, for cranial clamps 304.774 Neuro Insert Tray, for Battery Powered Screwdriver 304.775 Neuro Multi Clamp Insert Tray Instruments 1.1 mm Drill Bits, hex coupling 316.624 4 mm stop 316.626 6 mm stop 1.1 mm Drill Bits, Stryker J-Latch 317.14 4 mm stop 317.16 6 mm stop 1.3 mm Drill Bits, Stryker J-Latch 310.133 3 mm stop 310.136 4 mm stop 310.137 6 mm stop Titanium Low Profile Neuro Screws Low Profile Neuro Screws, self-drilling (with self-retaining cruciform recess) (5/pkg.) 400.833 3 mm length 400.834 4 mm length 400.835 5 mm length 400.836 6 mm length Low Profile Neuro Screws, self-tapping, (with self-retaining cruciform recess) (5/pkg.) 400.843 3 mm length 400.844 4 mm length 400.845 5 mm length 400.846 6 mm length Low Profile Neuro Emergency Screws, self-tapping, (with self-retaining cruciform recess) (5/pkg.) 400.853 3 mm length 400.854 4 mm length 400.855 5 mm length 400.856 6 mm length 1.3 mm Drill Bits, hex coupling 310.134 3 mm stop 310.138 4 mm stop 310.139 6 mm stop Screwdriver Handles with hex coupling 311.005 Small 311.006 Medium 311.007 Large Low Profile Neuro Cruciform Screwdriver Blades, self-retaining 313.931 Hex coupling, short 313.932 Hex coupling, medium 313.933 Mini quick coupling, short 329.14 Universal Bending Pliers 348.98 Plate Holding Forceps, Locking 391.952 Mesh Cutter Low Profile Neuro Plating System Surgical Technique DePuy Synthes 11

Low Profile Neuro System Titanium Low Profile Neuro Plates 421.501 Contourable Strut Plate, 8 holes 421.502 Straight Plate, 2 holes, 12 mm 421.503 Straight Plate, 2 holes, 9 mm 421.504 Straight Plate, 4 holes 421.510 X-Plate, 4 holes 421.511 Box Plate, 14 mm x 14 mm, 4 holes 421.512 Box Plate, 16 mm x 16 mm, 4 holes 421.515 Y-Plate, 5 holes 421.516 Double Y-Plate, 6 holes, 18 mm 421.517 Double Y-Plate, 6 holes, 21 mm 421.518 Adaption Plate, 5 holes 421.519 Adaption Plate, 7 holes 421.520 Adaption Plate, 20 holes 421.521 Box Plate, 10 mm x 16 mm, 4 holes 421.522 Strut Plate, 6 holes 421.523 Strut Plate, 8 holes Titanium Low Profile Neuro Burr Hole Covers 421.525 12 mm diameter 421.526 15 mm diameter 421.527 17 mm diameter 421.528 24 mm diameter 421.553 For shunt, 15 mm diameter 421.554 For shunt, 17 mm diameter Titanium Low Profile Neuro Contourable Mesh 421.500 Temporal Titanium Mesh Plate, malleable, medium 0.6 mm Rigid Mesh, silver 421.532 38 mm x 45 mm 421.534 100 mm x 100 mm 421.535 200 mm x 200 mm 421.538 Small arc 421.539 Large arc 421.543 30 mm diameter 421.544 70 mm diameter 421.545 100 mm diameter 0.4 mm Malleable Mesh, blue 421.531 38 mm x 45 mm 421.533 100 mm x 100 mm 421.536 Small arc 421.537 Large arc 421.540 30 mm diameter 421.541 70 mm diameter 421.542 100 mm diameter 421.546 Mastoid, large 421.547 Mastoid, medium Available nonsterile or sterile-packed. Add S to product number for sterile product. 11 DePuy Synthes Low Profile Neuro Plating System Surgical Technique

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 19380 Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132 To order (USA): 800-523-0322 To order (Canada): 855-946-8999 Note: For recognized manufacturer, refer to the product label. www.depuysynthes.com DePuy Synthes 2014 2017. All rights reserved. DSUS/CMF/0414/0067(1) 6/17 DV