Compact 2.0 LOCK Mandible. The locking system for the mandible.

Transcription

1 Compact 2.0 LOCK Mandible. The locking system for the mandible. Surgical Technique This publication is not intended for distribution in the USA. Instruments and implants approved by the AO Foundation.

2 Image intensifier control This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended. Processing, Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to: For general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to:

3 Table of Contents Introduction Compact 2.0 LOCK Mandible 2 AO Principles 4 Intended Use, Indications, Contraindications, 5 General Adverse Events, Device Specific Adverse Events, Warnings, Precautions, and MRI Information Surgical Technique Surgical Technique 9 Steps for Bone Resection (Optional) 17 Ordering Information Set 19 Plates 20 Screws 21 Instruments 23 Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 1

4 Compact 2.0 LOCK Mandible. The locking system for the mandible. System Features and Benefits Four plate profiles one screw dimension Low-profile plating system minimizes soft tissue irritation and implant palpability Choice of rigidity level depending on individual situation System covers a broad range of indications: small plates for simple trauma medium plates for extra stability if required large and extra-large plates for more complex trauma and microvascular reconstruction Choice of self-tapping or selfdrilling screws Provides locked or non-locked 2.0-mm screw-plate fixation 2.0-mm screws fit all plate profiles The locking design: Increases construct stability Minimizes the risk of stripped screw holes Decreases risk of screw back-out and subsequent loss of reduction Provides a positive stop for locking screws when inserted by power Reduces the need for precise anatomic plate contouring Preserves reduction intraoperatively by maintaining plate-to-bone position Plates Low plate profile with enhanced stability; favorable in atrophic mandibles (reduced risk of nerve damage) Easy three-dimensional contouring without plate hole deformation Less plate palpability Available in a wide variety of straight, angled and curved shapes Hole spacing is designed to optimize fixation in reconstructive surgery 1.0 Small 1.3 Medium 1.5 Large Extra-large DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

5 Screws 2.0-mm LOCK screw self-tapping and self-drilling Stable fixation of bone fragments and grafts, even with poor quality bone Reduced risk of screw loosening and movement Prevention of screw stripping Absence of plate pressure on the bone preserves blood supply Special conical double threads beneath the screw head engage and lock into threaded plate holes Available in 6 mm 18 mm lengths, for monocortical and bicortical applications Self-tapping for easy insertion Made of high-strength titanium alloy 2.0-mm Cortex Screw self-tapping and self-drilling (non locking) Without thread in the screw head, permits greater angulation of the screw in the 2.0 LOCK Mandible plate. Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 3

6 AO Principles In 1958, the AO (Association for the Study of Internal Fixation) formulated four basic principles, which have become the guidelines for internal fixation 1. Those principles as applied to the 2.0 LOCK Mandible system are: Anatomic reduction Fracture reduction and fixation to restore anatomical relationships. A comprehensive implant and instrument selection offers the ability to address most simple and complex fixation needs. Stable fixation Stability by rigid fixation (compression plating) or splintage, as the nature of the fracture and the injury requires. The Compact 2.0 LOCK Mandible locking plate and screw locking technology are optimized to achieve stable bone fixation. Preservation of blood supply Preservation of the blood supply to soft tissue and bone by careful handling and gentle reduction techniques. Instrumentation and new gentle profiles and edges on implants minimize disruption of soft tissue and preserves vascular blood flow for bone healing. Early mobilization Early and safe mobilization of the part and patient. The Compact 2.0 LOCK Mandible system implants, combined with AO technique, provide stable fixation enough to allow a functional aftercare. 1 Müller ME, Allgöwer M, Schneider R, Willenegger H. AO Manual of Internal Fixation. 3 rd edition. Berlin: Springer DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

7 Intended Use, Indications, Contraindications, General Adverse Events, Device Specific Adverse Events, Warnings, Precautions, and MRI Information Intended use The DePuy Synthes Plate and Screw System Compact Mandible is intended for oral, maxillofacial surgery, trauma, reconstructive surgery, and orthognathic surgery (surgical correction of dentofacial deformities). Indications Trauma: all fractures, defect fractures, and instable and infected mandibular fractures. Reconstructive surgery: bridging osteosynthesis with bone graft, both for primary and secondary reconstructions (tumor resections, pseudoarthrosis). Orthognathic surgery: selective orthognathic surgery of maxilla and chin. COMPACT 2.0 LOCK Mandible is indicated to be used for Mandible trauma, or thognathic surgery, and reconstructive surgery with microvascular bone grafts. Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 5

8 Intended Use, Indications, Contraindications, General Adverse Events, Device Specific Adverse Events, Warnings, Precautions, and MRI Information Indications Plate thickness Plate type Primary clinical use Secondary clinical use 1.0 mm Small plates: Tension band Straight Adaption Strut/Box/L/Y 1.3 mm Medium plates: Adaption plates Crescent Angled DCP plates Mandible traumatology Orthognathic 1.5 mm Large plates: Curved/Crescent Straight Angled Mandible traumatology NA 2.0 mm Extra large plates: Straight Single Angle Double Angle Mandible traumatology NA Primary mandibular reconstruction (used with microvascular bone graft) Comminuted fractures 6 DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

9 Contraindication COMPACT 2.0 Lock Mandible is contraindicated for Reconstructive surgery without microvascular bone grafts. General Adverse Events As with all major surgical procedures, risks, side effects, and adverse events can occur. While many possible reactions may occur, some of the most common include: Problems resulting from anesthesia and patient positioning (e.g. nausea, vomiting, dental injuries, neurological impairments, etc.), thrombosis, embolism, infection, nerve and/or tooth root damage or injury of other critical structures including blood vessels, excessive bleeding, damage to soft tissues including: swelling, abnormal scar formation, functional impairment of the musculoskeletal system, pain, discomfort or abnormal sensation due to the presence of the device, allergy or hypersensitivity reactions, side effects associated with hardware prominence, loosening, bending, or breakage of the device, mal-union, non-union or delayed union which may lead to breakage of the implant, or re-operation. Warnings: These devices can break intraoperatively when subjected to excessive forces or used outside the recommended surgical technique. While the surgeon must make the final decision on removal of the broken part based on the associated risk in doing so, we recommend that whenever possible and practical for the individual patient, the broken part be removed. Be aware that implants are not as strong as native bone. Implants subjected to substantial loads may fail. Precaution: Check instruments for wear or damage before starting surgery. Device Specific Adverse Events Device specific adverse events include but are not limited to: Loosening, bending, or breakage of the device Non-union, mal-union or delayed union which may lead to breakage of the implant Pain, discomfort or abnormal sensation due to the presence of the device Infection, nerve and/or tooth root damage and pain Soft tissue irritation, laceration or migration of the device through the skin Allergic reactions from material incompatibility Glove tear or user puncture Graft failure Restricted or impaired bone growth Possible transmission of blood-borne pathogens to the user Injury of patient Soft tissue thermal damage Bone necrosis Paresthesia Loss of tooth Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 7

10 Intended Use, Indications, Contraindications, General Adverse Events, Device Specific Adverse Events, Warnings, Precautions, and MRI Information MRI Information Magnetic Resonance Environment Torque, Displacement and Image Artifacts according to ASTM F , ASTM F e1 and ASTM F Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 5.4 T/m. The largest image artifact extended approximately 31 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system. Radio-Frequency-(RF-)induced heating according to ASTM F a Non-clinical electromagnetic and thermal simulations of worst case scenario lead to temperature rises of 13.7 C (1.5 T) and 6.5 C (3 T) under MRI Conditions using RF Coils (whole body averaged specific absorption rate [SAR] of 2 W/kg for 15 minutes). Precautions: The above mentioned test relies on non-clinical testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: It is recommended to thoroughly monitor patients undergoing MR scanning for perceived temperature and/or pain sensations. Patients with impaired thermoregulation or temperature sensation should be excluded from MR scanning procedures. Generally, it is recommended to use an MRI system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible. Using the ventilation system may further contribute to reduce temperature increase in the body. 8 DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

11 Surgical Technique 1 Exposure and reduction After completing the preoperative plan, expose the fracture or osteotomy site. For trauma, reduce the fracture as required. 2 Select and prepare implants Instrument Holding forceps for plates 1.0 to 2.4 Select the appropriate plate depending on indication. Orient the plate so that the topside of the plate is facing out. Determine the appropriate screw type (locking and/or non-locking, self-tapping and/or self-drilling). Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 9

12 Surgical Technique 3 Optional: Cut the plate to length Instrument Plate cutter with Deburring Device, for plates 1.0 to 2.4, length 180 mm Optional Bending/Cutting Pliers with Nose, for LOCK Plates 2.0 Small, medium and large plates Cut to length, if necessary. Small plates may be cut using the plate cutter or the bending/cutting pliers with nose. Precautions: Instrument tips and implant edges may be sharp, handle with care and dispose sharp cuttings in an approved sharps container. Take care to protect soft tissue from trimmed plate edges. Extra large plates Cut to length, if necessary. Extra large plates may be cut using the plate cutter. 11 DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

13 4 Select and form the bending template Select the appropriate shape and length bending template and form it to the boney anatomy. Notes: In case of trauma, at least three screws should be inserted on each side of the fracture. In case of tumor resection, at least four screws should be inserted on each side of the defect. 5 Contour the plate Instruments Pliers, flat-nosed, pointed, for Plates 1.0 to Combined Pliers for Plates 1.0 and 2.0, for Cutting and Bending Bending/Cutting Pliers with Nose, for LOCK Plates 2.0 Small and medium plates In-plane, out-of-plane and torsional bending Small and medium plates can be contured using the combined pliers and the flat nosed pliers. If using locking screws, it is not necessary to perfectly adapt the locking plates to the patient anatomy. The locking screws ensure plate stability without relying on contact between the plate and the underlying bone. Precautions: Avoid reverse bends as it may weaken the plate and lead to premature implant failure. Avoid sharp bends. Sharp bends include a single out-ofplane bend of >30 degrees between two adjacent holes. Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 11

14 Surgical Technique Large and extra large plates Can be contoured using the bending/cutting pliers with nose and the flat nosed pliers. In-plane bending Out-of-plane bending Bending the last hole out-of-plane with nose. Torsional bending Grasp the plate in the appropriate jaw of the flat nosed pliers, and apply a twisting motion until achieving the desired torsional bend. 11 DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

15 6 Position the plate and select screws Instrument Holding Forceps with Ball, ratchet lock, length 180 mm Place the plate over the fracture or osteotomy site. Use the plate holding forceps to secure the plate to the bone, if desired. Precaution: Avoid placing the holes over the nerve or tooth root. If plate requires placement over nerve or tooth root, drill monocortically using the appropriate drill bit with stop. Notes: In case of trauma, at least three screws should be inserted on each side of the fracture. In case of tumor resection, at least four screws should be inserted on each side of the defect. Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 11

16 Surgical Technique 7 Drill the first hole Option 1: Drill using standard drill sleeve/double drill guide Instruments Drill sleeve 1.5, for LOCK Plates Drill Bit B 1.5 mm, length 80 mm, 2-flute, for J-Latch Coupling Double Drill Guide 2.0/1.5 Insert the drill sleeve into the first plate hole nearest the fracture or osteotomy site. When using the standard drill sleeve/double drill guide with locking screws, ensure that it is centered in all planes to align the screw s locking threads properly in the plate. Note: Standard 1.5-mm drill sleeve and double drill guide to be used with non-locking screws or when good visualization is possible. Precautions: Avoid placing the holes over the nerve or tooth root. If plate requires placement over nerve or tooth root, drill monocortically using the appropriate drill bit with stop. 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 pull-out force, increased ease of the screws stripping in bone, suboptimal fixation, and/or the need for emergency screws. Avoid damaging the plate threads with the drill. Always irrigate during drilling to avoid thermal damage to the bone. Always irrigate and apply suction for removal of debris potentially generated during implantation or removal 11 DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

17 Option 2: Drill using threaded sleeve Instruments Drill Sleeve 1.5, with thread, for LOCK Plates Drill Bit B 1.5 mm, length 125 mm, 2-flute, for J-Latch Coupling When using the threaded drill sleeve, rotate the drill guide clockwise to engage the threads in the plate. Note: 1.5-mm threaded drill sleeve to be used with locking screws. 8 Measure screw length Instrument Depth Gauge for Screws B 1.5/2.0, measuring range up to 45 mm Determine the appropriate screw length using the depth gauge. Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 11

18 Surgical Technique 9 Insert the first screw Instruments Screwdriver Shaft PlusDrive 1.5/2.0, long, self-holding, for Hexagonal Coupling Handle, medium, with Hexagonal Coupling Insert the proper length 2.0-mm screw, cortex or locking screw, through the plate and tighten until secure. Insert the first screw adjacent to the fracture line or osteotomy site. Precaution: Tighten screws in a controlled manner. Applying too much torque to the screws may cause screw/plate deformation or bone stripping. 10 Drill holes and place the remaining screws Insert the second screw on the opposite side of the fracture or osteotomy site following the previously outlined procedure. Insert all remaining screws alternating to each side of the mandible. Securely tighten all screws unless resection is to follow. Apply additional fixation as desired. Note: Steps 11 to 13 refer exclusively to tumor resections. 11 DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

19 Steps for Bone Resection (Optional) 11 Resect the mandible Instruments Screwdriver Shaft PlusDrive 1.5/2.0, long, self-holding, for Hexagonal Coupling Handle, medium, with Hexagonal Coupling Once the plate is in place, remove the plate and screws, taking note of each screw s placement. Resect the mandible. 12 Reposition the implants Place the plate back onto the mandible in its original position. Reinsert each predetermined screw. Check all screws to ensure a secure fit in the plate. Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 11

20 Surgical Technique Steps for Bone Resection (Optional) 13 Apply bone graft 2 A vascularized bone graft must be applied to all 2.0 mm constructs used in reconstructing the mandible. Precaution: If no vascularized bone graft is applied, a 2.4 mm UniLOCK plate or larger system should be used. 2 Prein J. Manual of Internal Fixation in the Cranio-Facial Skeleton. Berlin: Springer DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

21 Ordering Information Set Compact 2.0 LOCK Mandible, PlusDrive Units Module Compact 2.0 LOCK Mandible, 3/3, with Lid, without Contents LOCK Plate 2.0, small, with centre space, 4 holes, length 28 mm, LOCK Plate 2.0, small, with centre space, 6 holes, length 40 mm, LOCK Mandible Adaption Plate 2.0, small, 20 holes, length 119 mm, LOCK Mandible Plate 2.0, medium, with centre space, 6 holes, length 43 mm, LOCK Mandible Plate 2.0, medium, 12 holes, length 77 mm, LOCK Mandible Plate 2.0, large, with centre space, 6 holes, length 53 mm, LOCK Mandible Plate 2.0, large, 6 holes, length 47 mm, LOCK Mandible Plate 2.0, large, 12 holes, length 95 mm, LOCK Mandible Plate 2.0, large, 20 holes, length 159 mm, LOCK Mandible Plate 2.0, angled, right, large, 6+21 holes, length 189/81 mm, LOCK Mandible Plate 2.0, angled, left, large, 6+21 holes, length 189/81 mm, C C C C C C C C C C C C C LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 5 mm,, pack of 4 units in Clip 2 LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 6 mm,, pack of 4 units in Clip 3 LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 8 mm,, pack of 4 units in Clip 3 LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 10 mm,, pack of 4 units in Clip 3 LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 12 mm,, pack of 4 units in Clip 3 LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 14 mm,, in Clip 4 LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 16 mm,, in Clip 4 LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 18 mm,, in Clip 4 Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 4 mm,, pack of 4 units in Clip 2 Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 6 mm,, pack of 4 units in Clip 3 Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 8 mm,, pack of 4 units in Clip 3 Emergency Screw PlusDrive B 2.4 mm, self-tapping, length 6 mm,, pack of 1 unit in Clip 4 Emergency Screw PlusDrive B 2.4 mm, self-tapping, length 8 mm,, pack of 1 unit in Clip Drill Sleeve 1.5, with thread, for LOCK Plates Screwdriver Shaft PlusDrive 1.5/2.0, long, self-holding, for Hexagonal Coupling Drill Bit B 1.5 mm, length 125 mm, 2-flute, for J-Latch Coupling Drill Bit B 1.5 mm, length 80 mm, 2-flute, for J-Latch Coupling Drill Bit B 1.5 mm with Stop, length 44.5/6 mm, 2-flute, for J-Latch Coupling Drill Bit B 1.5 mm with Stop, length 44.5/8 mm, 2-flute, for J-Latch Coupling Drill Bit B 1.5 mm with Stop, length 44.5/12 mm, 2-flute, for J-Latch Coupling Labelling Clips for Screws and Screwdriver Shafts B 2.0 mm, PlusDrive 1 Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 11

22 Ordering Information Also available Plates LOCK Mandible Plate 2.0, small, centre space 2.5 mm, 4 holes, length 31 mm,, flexible LOCK Mandible Plate 2.0, small, centre space 2.5 mm, 6 holes, length 44 mm,, flexible LOCK Plate 2.0, small, centre space 2.5 mm, 4 holes, length 31 mm, LOCK Plate 2.0, small, centre space 2.5 mm, 6 holes, length 44 mm, LOCK Adaption Plate 2.0, 12 holes, LOCK Mandible Adaption Plate 2.0, small, 20 holes, length 119 mm, LOCK Tension Band Plate 2.0, 4 holes, length 25 mm, LOCK Mandible Plate 2.0, small, centre space 3.4 mm, 4 holes, length 31 mm, LOCK Mandible Plate 2.0, curved, small, centre space 3.4 mm, 4 holes, length 29 mm, LOCK Mandible Plate 2.0, medium, with centre space, 6 holes, length 43 mm, LOCK Mandible Plate 2.0, medium, 12 holes, length 77 mm, LOCK Mandible Plate 2.0, large, with centre space, 6 holes, length 53 mm, LOCK Mandible Plate 2.0, large, 6 holes, length 47 mm, LOCK Mandible Plate 2.0, large, 12 holes, length 95 mm, LOCK Mandible Plate 2.0, large, 20 holes, length 159 mm, LOCK Mandible Plate 2.0, angled, right, large, 6+21 holes, length 189/81 mm, LOCK Mandible Plate 2.0, angled, left, large, 6+21 holes, length 189/81 mm, LOCK Mandible Plate 2.0, large, crescent-shaped, 3+3 holes, LOCK Mandible Plate 2.0, angled, large, 3+3 holes, LOCK Mandible Plate 2.0, angled, large, 4+4 holes, LOCK DCP Mandible Plate 2.0, medium, 4 holes, LOCK DCP Mandible Plate 2.0, medium, 5 holes, LOCK DCP Mandible Plate 2.0, medium, 6 holes, LOCK DCP Mandible Plate 2.0, medium, 8 holes, LOCK DCP Mandible Plate 2.0, medium, angled, 6 holes, LOCK DCP Mandible Plate 2.0, medium, angled, 8 holes, LOCK Mandible Plate 2.0, medium, crescent, 5 holes, LOCK Mandible Plate 2.0, medium, crescent, 7 holes, LOCK Tension Band Plate 2.0, right, prebent, 4 holes, LOCK Tension Band Plate 2.0, left, prebent, 4 holes, LOCK Plate 2.0, double-row, 12 holes,, malleable LOCK Plate 2.0, double-row, 9 holes,, malleable LOCK Frame Plate 2.0, square, 4 holes,, malleable LOCK Strut Plate 2.0, 8 holes,, flexible LOCK Strut Plate 2.0, curved, 8 holes,, flexible LOCK Double-Y-Plate 2.0,, flexible LOCK L-Plate 2.0, right,, flexible LOCK L-Plate 2.0, left,, flexible LOCK Mandible Plate 2.0, large, double-angled, holes, LOCK Mandible Plate 2.0, large, double-angled, holes, LOCK Mandible Plate 2.0, large, double-angled, holes, LOCK Mandible Plate 2.0, extra-large, 12 holes, LOCK Mandible Plate 2.0, extra-large, 20 holes, LOCK Mandible Plate 2.0, right, extra-large, 6+21 holes, LOCK Mandible Plate 2.0, left, extra-large, 6+21 holes, LOCK Mandible Plate 2.0, double-angled, extra-large, holes, LOCK Mandible Plate 2.0, double-angled, extra-large, holes, LOCK Mandible Plate 2.0, double-angled, extra-large, holes, 22 DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

23 Screws LOCK Screw PlusDrive B 2.0 mm, self-tapping LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 5 mm, LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 6 mm, LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 8 mm, LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 10 mm, LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 12 mm, LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 14 mm, LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 16 mm, LOCK Screw PlusDrive B 2.0 mm, self-tapping, length 18 mm, LOCK Screw PlusDrive B 2.0 mm, self-drilling LOCK Screw PlusDrive B 2.0 mm, self-drilling, length 5 mm, LOCK Screw PlusDrive B 2.0 mm, self-drilling, length 6 mm, LOCK Screw PlusDrive B 2.0 mm, self-drilling, length 8 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 4 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 5 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 6 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 8 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 10 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 12 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 14 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 16 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 18 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 20 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 22 mm, Cortex Screw PlusDrive B 2.0 mm, self-tapping, length 24 mm, Cortex Screw PlusDrive B 2.0 mm, self-drilling Cortex Screw PlusDrive B 2.0 mm, self-drilling, length 4 mm, Cortex Screw PlusDrive B 2.0 mm, self-drilling, length 5 mm, Cortex Screw PlusDrive B 2.0 mm, self-drilling, length 6 mm, Cortex Screw PlusDrive B 2.0 mm, self-drilling, length 7 mm, Cortex Screw PlusDrive B 2.0 mm, self-drilling, length 8 mm, MF Cortex Screw B 2.0 mm, self-tapping MF Cortex Screw B 2.0 mm, self-tapping, length 4 mm, MF Cortex Screw B 2.0 mm, self-tapping, length 6 mm, MF Cortex Screw B 2.0 mm, self-tapping, length 8 mm, MF Cortex Screw B 2.0 mm, self-tapping, length 10 mm, MF Cortex Screw B 2.0 mm, self-tapping, length 12 mm, MF Cortex Screw B 2.0 mm, self-tapping, length 14 mm, MF Cortex Screw B 2.0 mm, self-tapping, length 16 mm, MF Cortex Screw B 2.0 mm, self-tapping, length 18 mm, Cortex Screw B 2.0 mm, length 20 mm, Cortex Screw B 2.0 mm, length 22 mm, Cortex Screw B 2.0 mm, length 24 mm, Cortex Screw B 2.0 mm, length 26 mm, Cortex Screw B 2.0 mm, length 28 mm, Cortex Screw B 2.0 mm, length 30 mm, Cortex Screw B 2.0 mm, length 32 mm, Mandible Cortex Screw B 2.0 mm, self-tapping Mandible Cortex Screw B 2.0 mm, self-tapping, length 4 mm, Mandible Cortex Screw B 2.0 mm, self-tapping, length 6 mm, Mandible Cortex Screw B 2.0 mm, self-tapping, length 8 mm, Mandible Cortex Screw B 2.0 mm, self-tapping, length 10 mm, Mandible Cortex Screw B 2.0 mm, self-tapping, length 12 mm, Mandible Cortex Screw B 2.0 mm, self-tapping, length 14 mm, Mandible Cortex Screw B 2.0 mm, self-tapping, length 16 mm, Mandible Cortex Screw B 2.0 mm, self-tapping, length 18 mm, Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 21

24 Ordering Information MF Monocortical Screw B 2.0mm MF Monocortical Screw B 2.0 mm, self-tapping, length 4 mm, MF Monocortical Screw B 2.0 mm, self-tapping, length 6 mm, MF Monocortical Screw B 2.0 mm, self-tapping, length 8 mm, Emergency Screw PlusDrive B 2.4 mm, self-tapping Emergency Screw PlusDrive B 2.4 mm, self-tapping, length 5 mm, Emergency Screw PlusDrive B 2.4 mm, self-tapping, length 6 mm, Emergency Screw PlusDrive B 2.4 mm, self-tapping, length 8 mm, Emergency Screw PlusDrive B 2.4 mm, self-tapping, length 10 mm, Emergency Screw PlusDrive B 2.4 mm, self-tapping, length 12 mm, Emergency Screw PlusDrive B 2.4 mm, self-tapping, length 14 mm, Emergency Screw PlusDrive B 2.4 mm, self-tapping, length 16 mm, Emergency Screw PlusDrive B 2.4 mm, self-tapping, length 18 mm, Emergency Screw B 2.4 mm, self-tapping Emergency Screw B 2.4 mm, self-tapping, length 6 mm,, blue Emergency Screw Cruciform Recess B 2.4 mm, self-tapping, length 8 mm,, blue Emergency Screw Cruciform Recess B 2.4 mm, self-tapping, length 10 mm,, blue Emergency Screw Cruciform Recess B 2.4 mm, self-tapping, length 12 mm,, blue Ordering information* Screws Plates Packs of 1 unit xxx.xxx xxx.xxx Packs of 1 unit with clip xxx.xxx.01c n/a Packs of 4 units with clip xxx.xxx.04c n/a Packs of 1 unit, sterile n/a xxx.xxxs Packs of 1 unit with clip, sterile xxx.xxxs n/a Packs of 4 units with clip, sterile xxx.xxx.04s n/a * not all packaging variations are available for all items Instruments Countersink with Centering Pin, for Screws B 2.0 mm with Hexagonal Coupling Drill Sleeve 1.5, short, with thread, for LOCK Mandible Plates Drill Sleeve 1.5, with thread, long, for LOCK Mandible Plates Bending Template for LOCK Mandible Plate 2.0, crescent-shaped, 5+7 holes, length 42 mm Bending Template for LOCK DCP Mandible Plate 2.0, angled, 6+8 holes, length 42 mm Bending Template for LOCK DCP Mandible Plate 2.0, holes, length 68 mm Bending Template for LOCK Mandible Plate 2.0, double-angled, holes, length 202 mm Bending Template for LOCK Mandible Plate 2.0, double-angled, holes, length 221 mm Bending Template for LOCK Mandible Plate 2.0, double-angled, holes, length 240 mm Standard Instruments Compact 2.0 Mandible, 3/3, with Lid Units Instrument Tray Compact 2.0 Mandible, 3/3, with Lid Pliers, flat-nosed, pointed, for Plates 1.0 to Holding Forceps for Plates 1.0 to Holding Forceps for Cortex Screws B 1.0 to 2.4 mm Combined Pliers for Plates 1.0 to 2.0, for Cutting and Bending Depth Gauge for Screws B 1.5 to 2.0 mm, measuring range up to 45 mm Handle, medium with Hexagonal Coupling Double Drill Guide 2.0/ Plate Cutter with Deburring Device, for Plates 1.0 to 2.4, length 180 mm LOCK Screwdriver Shaft PlusDrive 1.5/2.0, short, self-holding, for Hexagonal Coupling Screwdriver Shaft PlusDrive 1.5/2.0, long, self-holding, for Hexagonal Coupling Drill Bit B 1.5 mm, length 80 mm, 2-flute, for J-Latch Coupling Drill Bit B 1.5 mm, length 125 mm, 2-flute, for J-Latch Coupling Drill Bit B 2.0 mm, length 80 mm, 2-flute, for J-Latch Coupling Drill Bit B 2.0 mm, length 125 mm, 2-flute, for J-Latch Coupling Drill Bit B 1.5 mm, length 80 mm, 2-flute, for Mini Quick Coupling Drill Bit B 1.5 mm, length 125 mm, 2-flute, for Mini Quick Coupling Drill Bit B 2.0 mm, length 80 mm, 2-flute, for Mini Quick Coupling Drill Bit B 2.0 mm, length 125 mm, 2-flute, for Mini Quick Coupling Drill Bit B 1.5 mm with Stop, length 44.5/4 mm, 2-flute, for J-Latch Coupling Drill Bit B 1.5 mm with Stop, length 44.5/6 mm, 2-flute, for J-Latch Coupling Drill Bit B 1.5 mm with Stop, length 44.5/8 mm, 2-flute, for J-Latch Coupling 22 DePuy Synthes Compact 2.0 LOCK Mandible Surgical Technique

25 Drill Bit B 1.5 mm with Stop, length 44.5/12 mm, 2-flute, for J-Latch Coupling Drill Bit B 1.5 mm with Stop, length 44.5/4 mm, 2-flute, for Mini Quick Coupling Drill Bit B 1.5 mm with Stop, length 44.5/6 mm, 2-flute, for Mini Quick Coupling Drill Bit B 1.5 mm with Stop, length 44.5/8 mm, 2-flute, for Mini Quick Coupling Drill Bit B 1.5 mm with Stop, length 44.5/12 mm, 2-flute, for Mini Quick Coupling Bending Template for LOCK Mandible Plate 2.0, large, angled, 6+21 holes, right Bending Template for LOCK Mandible Plate 2.0, large, angled, 4+4 holes Bending Template for LOCK Mandible Plate 2.0, large, crescent-shaped, 3+3 holes Bending Template for LOCK Mandible Plate 2.0, large, 20 holes Bending Template for LOCK Mandible Plate 2.0, medium, with centre space, 6 holes Bending Template for LOCK Mandible Plate 2.0, large, with centre space, 6 holes Bending Template for LOCK Mandible Plate 2.0, medium, 12 holes Bending Template for LOCK Mandible Plate 2.0, large, angled, 6+21 holes, left Drill Sleeve 1.5, short, with thread, for LOCK Mandible Plates 2.0 Optional Bending/Cutting Pliers with Nose, for LOCK Plates Holding Forceps with Ball, ratchet lock, length 180 mm Drill sleeve 1.5, for Lock Plates Drill Sleeve 1.5, with thread, for LOCK Plates 2.0 Compact 2.0 LOCK Mandible Surgical Technique DePuy Synthes 22

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28 DSEM/CMF/0115/0051(1) 06/16 Synthes GmbH Eimattstrasse Oberdorf Switzerland Tel: Fax: Not all products are currently available in all markets. This publication is not intended for distribution in the USA. All surgical techniques are available as PDF files at DePuy Synthes CMF, a division of Synthes GmbH All rights reserved