MatrixNEURO Cranial Plating System

Transcription

1 The Next Generation Cranial Plating System MatrixNEURO Cranial Plating System Surgical Technique

2 TABLE OF CONTENTS INTRODUCTION MatrixNEURO Cranial Plating System 2 MatrixNEURO Reconstruction Mesh 6 MatrixNEURO Preformed Mesh 7 SURGICAL TECHNIQUE Technique 8 PRODUCT INFORMATION MatrixNEURO Plates 13 MatrixNEURO Mesh 16 MatrixNEURO Reconstruction Mesh 18 MatrixNEURO Preformed Mesh 19 Instruments 20 MatrixNEURO Module and Accessories 22 MatrixNEURO Sterile Kit 24 MR Information The MatrixNEURO Cranial 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 MatrixNEURO Cranial Plating System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. MatrixNEURO TM Cranial Plating System Surgical Technique DePuy Synthes 1

3 MatrixNEURO CRANIAL 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. Plate and screw osteosynthesis has been established and clinically recognized for some time. Keeping the AO philosophy at its core, MatrixNEURO System is a plating platform for internal fixation of the craniomaxillofacial skeleton addressing neuro, craniofacial, mandibular, and orthognathic surgery. MatrixNEURO System is a streamlined, comprehensive system that offers flexibility, ease of use, and the highest quality implants and instruments. 2 DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

4 MatrixNEURO Cranial Plating System 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. Medical devices containing stainless steel may elicit an allergic reaction in patients with hypersensitivity to nickel. 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. MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 3

5 MatrixNEURO Cranial Plating System Indications The DePuy Synthes MatrixNEURO Cranial 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 and chin. MatrixNEURO Cranial Plating System Low plate/screw profile of 0.5 mm for minimal implant palpability Self-drilling screws for fast closure of bone flaps and rapid fixation of cranial fractures Screwdriver blade provides secure, reliable screw/blade retention MatrixNEURO Self-Drilling Screws Unique thread design for rapid screw starting and low insertion torque Available in 3 mm 5 mm lengths For use with all MatrixNEURO Plates and Mesh MatrixNEURO Plates Plates are only 0.4 mm thick Full selection of titanium plates and burr hole covers MatrixNEURO Ultra Low Profile Plates Low plate/screw profile of 0.4 mm preserves patient cosmesis Plates are only 0.3 mm thick Chamfered edges and wide profile for virtually no palpability Construct stiffness and strength is comparable to MatrixNEURO Plates Color-coded (light green) for easy identification For use with MatrixNEURO Self-Drilling Screws 4 DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

6 MatrixNEURO Cranial Plating System MatrixNEURO Contourable Mesh Available in a variety of shapes and sizes Design allows screw placement through either side of mesh Color-coded based on strength characteristic: 0.4 mm malleable 0.4 mm rigid 0.6 mm rigid 0.6 mm very rigid Mesh strength gradient MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 5

7 MatrixNEURO RECONSTRUCTION MESH Indications The DePuy Synthes MatrixNEURO Reconstruction Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.* MatrixNEURO Reconstruction Mesh Our most rigid MatrixNEURO Mesh Single-sided, low 0.6 mm profile Benders for contouring without kinking Available in a variety of shapes and sizes for reconstructing cranial defects For use with MatrixNEURO Self-Drilling Screws 82% more rigid than MatrixNEURO 0.6 mm Pink Mesh** 0.4 mm malleable 0.4 mm rigid 0.6 mm rigid 0.6 mm very rigid Mesh strength gradient **Not available for sale in Canada. ** Data on file. Bench test results may not necessarily be indicative of clinical performance. 6 DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

8 MatrixNEURO PREFORMED MESH Indications The DePuy Synthes MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.* 0.4 mm malleable 0.4 mm rigid 0.6 mm rigid 0.6 mm very rigid Mesh strength gradient MatrixNEURO Preformed Mesh Preformed Mesh is 82% more rigid than MatrixNEURO 0.6 mm Pink Mesh** Anatomical shapes to fit an average skull Provides rigid construct for a variety of cranial defect reconstructions Mesh pattern allows for anatomical contouring without kinking OR convenience for use with MatrixNEURO Screws 2x FTP (R/L) 2x Temporal (R/L) 1x Universal 1x Frontal Single-sided design allows for low, 0.6 mm profile Note: Three holes at the apex of each implant are not countersunk. **Not available for sale in Canada. ** Data on file. Bench test results may not necessarily be indicative of clinical performance. Kamer, Lukas, MD, DDS, Noser Hansrudi, PhD, Hammer, Beat, MD, DDS; Anatomical Background for the Development of Preformed Cranioplasty Implants; The Journal of Craniofacial Surgery, 2013: MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 7

9 SURGICAL TECHNIQUE 1 Select Implant Select the appropriate implants listed on pages The MatrixNEURO Cranial Plating System contains a wide variety of plates, burr hole covers, mesh, and screws. Precaution: When using plates, preformed or reconstruction mesh, ensure countersink holes are facing upward. 2 Size implant (if required) Instruments Cutting Scissors for Mesh Plates, short nose Cutting Scissors for Mesh Plates, long nose Reconstruction Mesh Cutters Implants may be cut and sized to match the patient s anatomy. 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. Reconstruction Mesh (gold) and Preformed (Temporal, Frontal, Universal, FTP) Mesh Plates can only be cut with the MatrixNEURO Cutter for Reconstruction Mesh Plates ref.: While handling the cut mesh, avoid the sharp edges. A B 8 DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

10 Surgical Technique 3 Contour implant (if required) Instruments Mini Plate Bender, locking Mini Plate Bender, non-locking Recon Mesh Benders The implant can be contoured to match the patient s anatomy. Precautions: Avoid contouring of the implant in situ as that may lead to implant malposition. Excessive and repetitive bending of the implant increases the risk of implant breakage. Reconstruction Mesh (gold) and Preformed (Temporal, Frontal, Universal, FTP) Mesh Plates can only be bent with the Reconstruction Mesh Benders ref.: After implant placement is complete, discard any fragments or modified parts in an approved container. 4 Position implant Instruments Mini Plate Holder, short Mini Plate Holder, long Position the implant on the desired location using the appropriate plate holder. MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 9

11 Surgical Technique Precaution: When using plates, Reconstruction Mesh (gold), or Preformed (Temporal, Frontal, Universal, FTP) Mesh Plates, ensure countersink holes are facing upwards. 5 Predrill screw holes (optional) Instruments mm Drill Bit, hex coupling, 4 mm stop, 52 mm mm Drill Bit, Stryker J-Latch coupling, 4 mm stop, 44.5 mm Precautions: Predrill in dense bone when using 5 mm screws. Use only a 1.1 mm drill bit for predrilling. 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. Avoid damaging the plate threads with the drill. Always irrigate during drilling to avoid thermal damage to the bone. Irrigate and apply suction for removal of debris potentially generated during implantation or removal. 6 Secure implant Instruments MatrixNEURO Screwdriver Blade, hex coupling, self-retaining, short MatrixNEURO Screwdriver Blade, hex coupling, self-retaining, medium Screwdriver Handle, hex coupling, small 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 Screwdriver Handle, hex coupling, large 11 DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

12 Surgical Technique For optimal plate/screw profile, insert the screw perpendicular to the plate in the appropriate plate hole. If the self-drilling screw does not obtain purchase, replace it with a MatrixNEURO Emergency Screw of the same length. Precautions: Screwdriver shafts are self-retaining instruments. Replace worn or damaged screwdriver shafts if the retention is not adequate. Fully engage the shaft perpendicular to the screwhead. Place the 1.5 mm self-drilling screw perpendicular to the bone at the appropriate plate or mesh hole. Consider an appropriate length of screw to avoid injury of underlying structure with screws that are too long or plate loosening and/or migration with screws that are too short. Take care not to overtighten the screw. For Preformed Mesh Plates ref.: S, S, S, S, S and S, screws placed into non-countersunk holes will lead to a higher profile compared to screws placed into countersunk holes. MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 11

13 Surgical Technique Note: Secure the implants to the bone flap before positioning the bone flap on the patient Secure the desired plates to bone flap. 2. Position the bone flap. 3. Secure the plates to the skull. Precautions: In order to determine the appropriate amount of fixation for stability, the surgeon should consider the size and shape of a 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, irrigate and apply suction for removal of debris potentially generated during implantation DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

14 MatrixNEURO PLATES (shown actual size) Titanium MatrixNEURO Burr Hole Cover, 17 mm, blue Also available in 12 mm, 15 mm, and 24 mm, see page Titanium MatrixNEURO Burr Hole Cover, 17 mm, for shunt, blue Also available in 12 mm, 15 mm, and 24 mm, see page Titanium MatrixNEURO Straight Plate, 2 holes, 12 mm, blue Also available in 2 holes, 9 mm, see page Titanium MatrixNEURO Straight Plate, 4 holes, blue Titanium MatrixNEURO X-Plate, blue Titanium MatrixNEURO Box Plate, 14 mm x 14 mm, blue Also available in 10 mm x 16 mm and 16 mm x 16 mm, see page 25 MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 11

15 MatrixNEURO Plates (shown actual size) Titanium MatrixNEURO Y-Plate, 5 holes, blue Titanium MatrixNEURO Double Y-Plate, 6 holes, 18 mm, blue Also available in 6 holes, 21 mm, see page Titanium MatrixNEURO Adaption Plate, 7 holes, blue Also available in 5 holes and 20 holes, see page Titanium MatrixNEURO Strut Plate, 2 x 3 holes, blue Also available in 2 x 4 holes, see page Titanium MatrixNEURO Curved Strut Plate, 2 x 4 holes, blue Also available in 2 x 3 holes, see page Titanium Ultra Low Profile MatrixNEURO Burr Hole Cover, 12 mm diameter, light green Also available in 15 mm, 17 mm, and 24 mm, see page Titanium Ultra Low Profile MatrixNEURO Burr Hole Cover, 17 mm diameter, for shunt, light green 11 DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

16 MatrixNEURO Plates (shown actual size) Titanium Ultra Low Profile MatrixNEURO Straight Plate, 2 holes, 9 mm, light green Also available in 12 mm and 4 holes, see page Titanium Ultra Low Profile MatrixNEURO X-Plate, light green Titanium Ultra Low Profile MatrixNEURO Box Plate, 14 mm x 14 mm, light green Titanium Ultra Low Profile MatrixNEURO Double Y-Plate, 6 holes, 18 mm, light green Titanium Ultra Low Profile MatrixNEURO Box Plate, 10 mm x 16 mm, light green Titanium Ultra Low Profile MatrixNEURO Strut Plate, 2 x 3 holes, light green MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 11

17 MatrixNEURO MESH (shown actual size) 0.4 mm malleable 0.4 mm rigid 0.6 mm rigid 0.6 mm very rigid Mesh strength gradient Titanium MatrixNEURO Strut Mesh, silver, malleable Titanium MatrixNEURO Temporal Mesh, medium, silver, malleable Titanium MatrixNEURO Contourable Mesh, 30 mm diameter, silver, 0.4 mm malleable Also available in other shapes and sizes, see page Titanium MatrixNEURO Contourable Mesh, 30 mm diameter, blue, 0.4 mm rigid Also available in other shapes and sizes, see page Titanium MatrixNEURO Contourable Mesh, 30 mm diameter, pink, 0.6 mm rigid Also available in other shapes and sizes, see page DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

18 MatrixNEURO Mesh Titanium MatrixNEURO Contourable Mesh, mastoid, small, silver, malleable Also available in medium and large, see page 25 MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 11

19 MatrixNEURO RECONSTRUCTION MESH 0.4 mm malleable 0.4 mm rigid 0.6 mm rigid 0.6 mm very rigid Mesh strength gradient S Titanium MatrixNEURO Flat Reconstruction Mesh, square, 100 mm x 100 mm, gold, sterile Also available 150 mm x 150 mm and 200 mm x 200 mm, see page S Titanium MatrixNEURO Flat Reconstruction Mesh, round, diameter 70 mm, gold, sterile Also available diameter 100 mm, see page DePuy Synthes MatrixNEURO TM Plating System Surgical Technique

20 MatrixNEURO PREFORMED MESH S Ti MatrixNEURO Preformed Mesh 99 mm x 66 mm Temporal, Left Gold-Sterile Also available for right side 66 mm 99 mm S Ti MatrixNEURO Preformed Mesh 151 mm x 125 mm FTP, Left Gold-Sterile Also available for right side 125 mm 151 mm S Ti MatrixNEURO Preformed Mesh 109 mm x 78 mm Frontal Gold-Sterile 78 mm 109 mm S Ti MatrixNEURO Preformed Mesh 109 mm dia. Universal Gold-Sterile 109 mm MatrixNEURO TM Plating System Surgical Technique DePuy Synthes 11

21 INSTRUMENTS MatrixNEURO Screwdriver Blade, hex coupling, self-retaining, short MatrixNEURO Screwdriver Blade, hex coupling, self-retaining, medium Mini Plate Bender, locking Mini Plate Bender, nonlocking Mesh Cutting Scissors, short nose Also available in long nose Reconstruction Mesh Benders Reconstruction Mesh Cutters 22 DePuy Synthes MatrixNEURO TM Plating System Surgical Technique

22 Instruments Mini Plate Holder, long Also available in short, see page Screwdriver Handle with hex coupling, small Screwdriver Handle with hex coupling, medium Screwdriver Handle with hex coupling, large mm Drill Bit, hex coupling, 4 mm stop, 52 mm mm Drill Bit, Stryker J-Latch coupling, 4 mm stop, 44.5 mm MatrixNEURO TM Plating System Surgical Technique DePuy Synthes 22

23 MODULE AND ACCESSORIES MatrixNEURO Cranial Plating System Module and Accessories MatrixNEURO Implant and Instrument Set W Screw Length Marker, for 3 mm self-drilling screws W Screw Length Marker, for 4 mm self-drilling screws W Screw Length Marker, for 5 mm self-drilling screws MatrixNEURO Compact Module MatrixNEURO Instrument Module Plate Insert, adjustable, for MatrixNEURO Implant Module Screw Insert, for MatrixNEURO Implant Module Label Sheet for MatrixNEURO Module Neuro Insert Tray, for MatrixNEURO Instruments Neuro Insert Tray, for MatrixNEURO Instruments and Battery Powered Driver Ultra Low Profile Plate Insert, for MatrixNEURO Module Ultra Low Profile Label Sheet, for MatrixNEURO Module MatrixNEURO Strength Gradient Label Sheet (top) (fits in ) (bottom) For detailed cleaning and sterilization instructions, please refer to or sterilization instructions, if provided. 22 DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

24 Module and Accessories MatrixNEURO Cranial Plating System Trays and Accessories Universal Instrument Tray, large, deep * Neuro Instrument Tray Lid, large Screw Insert, for MatrixNEURO Implant Module (shown installed in module ) Neuro Insert Tray, for MatrixNEURO Instruments Universal Instrument Tray, large, deep * Neuro Instrument Tray Lid, large Plate Insert, adjustable, for MatrixNEURO Implant Module (shown installed in module ) Neuro Insert Tray, for MatrixNEURO Instruments and BPD Universal Instrument Tray, extra large, deep * Neuro Instrument Tray Lid, extra large Neuro Insert Tray, for Cranial Clamps Neuro Insert Tray, for MatrixNEURO Instruments and BPD Instrument Insert for Tray MatrixNEURO Strength Gradient label sheet Instrument Case for MatrixNEURO Mesh (includes lid and Instrument Insert) * Lids not shown MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 22

25 MatrixNEURO STERILE KIT MatrixNEURO Sterile Kit Ready-to-use sterile packs for one standard craniotomy closure Simplified ordering Plate/screw profile of 0.5 mm for minimal implant palpability MatrixNEURO Self-Drilling Screw for rapid and easy insertion S MatrixNEURO Sterile Kit, Standard, 4 mm Titanium MatrixNEURO Straight Plate, 2 holes, 12 mm, 3/pkg Titanium MatrixNEURO Screw, self-drilling, 4 mm, 6/pkg S MatrixNEURO Sterile Kit, 17 mm, Burr Hole Cover, 4 mm Titanium MatrixNEURO Burr Hole Cover, 17 mm, 1/pkg Titanium MatrixNEURO Straight Plate, 2 holes, 12 mm, 2/pkg Titanium MatrixNEURO Screw, self-drilling, 4 mm, 8/pkg. Instruments needed** MatrixNEURO Screwdriver Blade, hex coupling, self-retaining, medium Screwdriver Handle, medium, with hex coupling ** Handles and blades available in additional sizes and lengths, see page DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

26 MatrixNEURO Sterile Kit Titanium MatrixNEURO Screws Self-drilling mm, 5/pkg mm, 5/pkg mm, 5/pkg mm, 20/pkg mm, 20/pkg mm, 20/pkg. Emergency mm, 5/pkg mm, 5/pkg mm, 5/pkg. Titanium MatrixNEURO Ultra Low Profile Plates Straight Plate, 2 holes, 9 mm, light green Straight Plate, 2 holes, 12 mm, light green Straight Plate, 4 holes, light green X-Plate, light green Box Plate, 14 mm x 14 mm, light green Double Y-Plate, 6 holes, 18 mm, light green Box Plate, 10 mm x 16 mm, light green Strut Plate, 2 x 3 holes, light green Titanium MatrixNEURO Plates Straight Plate, 2 holes, 9 mm, blue Straight Plate, 2 holes, 12 mm, blue Straight Plate, 4 holes, 24 mm, blue X-Plate, blue Box Plate, 14 mm x 14 mm, blue Box Plate, 16 mm x 16 mm, blue Box Plate, 10 mm x 16 mm, blue Y-Plate, 5 holes, blue Double Y-Plate, 6 holes, 18 mm, blue Double Y-Plate, 6 holes, 21 mm, blue Adaption Plate, 5 holes, blue Adaption Plate, 7 holes, blue Adaption Plate, 20 holes, blue Strut Plate, 2 x 3 holes, blue Strut Plate, 2 x 4 holes, blue Curved Strut Plate, 2 x 3 holes, blue Curved Strut Plate, 2 x 4 holes, blue Titanium MatrixNEURO Ultra Low Profile Burr Hole Covers Burr Hole Cover, 12 mm, light green Burr Hole Cover, 15 mm, light green Burr Hole Cover, 17 mm, light green Burr Hole Cover, 24 mm, light green Burr Hole Cover, 17 mm, for shunt, light green Titanium MatrixNEURO Burr Hole Covers mm, blue mm, blue mm, blue mm, blue mm, for shunt, blue mm, for shunt, blue mm, for shunt, blue mm, for shunt, blue Titanium MatrixNEURO Contourable Mesh 0.4 mm Contourable Mesh Strut Mesh, silver, malleable Temporal Mesh, medium, silver, malleable Mastoid, small, silver, malleable Mastoid, medium, silver, malleable Mastoid, large, silver, malleable Titanium MatrixNEURO Contourable Mesh 0.6 mm Rigid Mesh mm x 45 mm, pink mm x 100 mm, pink mm x 200 mm, pink S 200 mm x 200 mm, pink, sterile Small arc, pink Large arc, pink mm diameter, pink mm diameter, pink mm diameter, pink MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 22

27 MatrixNEURO Sterile Kit Titanium MatrixNEURO Contourable Mesh 0.4 mm Rigid Mesh mm x 45 mm, blue mm x 100 mm, blue mm x 200 mm, blue Small arc, blue Large arc, blue mm diameter, blue mm diameter, blue mm diameter, blue 0.4 mm Malleable Mesh mm x 45 mm, silver mm x 100 mm, silver Small arc, silver Large arc, silver mm diameter, silver mm diameter, silver mm diameter, silver MatrixNEURO Instruments MatrixNEURO Screwdriver Blade, hex coupling, self-retaining, short MatrixNEURO Screwdriver Blade, hex coupling, self-retaining, medium Mini Plate Bender, locking Mini Plate Bender, nonlocking Mini Plate Holder, short Mesh Cutting Scissors, short nose Mini Plate Holder, long Mesh Cutting Scissors, long nose Reconstruction Mesh Benders Reconstruction Mesh Cutters Screwdriver Handle with hex coupling, small Screwdriver Handle with hex coupling, medium Screwdriver Handle with hex coupling, large mm Drill Bit, hex coupling, 4 mm stop, 52 mm mm Drill Bit, Stryker J-Latch, 4 mm stop, 44.5 mm 22 DePuy Synthes MatrixNEURO Cranial Plating System Surgical Technique

28 MatrixNEURO Sterile Kit Titanium MatrixNEURO Reconstruction Mesh 0.6 mm Rigid Mesh S 100 mm x 100 mm, gold, sterile S 150 mm x 150 mm, gold, sterile S 200 mm x 200 mm, gold, sterile S 70 mm diameter, gold, sterile S 100 mm diameter, gold, sterile Titanium MatrixNEURO Preformed Mesh 0.6 mm Rigid Mesh S 99 mm x 66 mm Temporal Left, Sterile S 99 mm x 66 mm Temporal Right, Sterile S 151 mm x 125 mm FTP Left, Sterile S 151 mm x 125 mm FTP Right, Sterile S 109 mm x 78 mm Frontal, Sterile S 109 mm dia. Universal, Sterile MatrixNEURO Cranial Plating System System Surgical Technique DePuy Synthes 22

29 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/0414/0015(2) 6/17 DV