TORNIER MAXLOCK EXTREME Clavicle Plating System SURGICAL TECHNIQUE
2
Table of Contents: Key Design Features...4 Surgical Technique...5 Implants & Instruments...9 3
Key Design Features There are 7 anatomically contoured plates available for both superior and anterior application. These low-profile plates range in thickness from 2.4 mm to 1.8 mm. Superior Plate: One plate size with 10.5 degree bend and compression capabilities. Multi-planar fixation and tubular design allows for best fit and maximum fixation. Lateral Plate: Short and long sizes available in both left and right. The plate design allows for 4 screws in the distal fragment. Anterior Plate: Short and long sizes available with a tubular design and multi-planar fixation medially. Custom Soft Tissue Protector: Used to protect brachial plexus and supra clavicular nerves when drilling bi-cortically. Key-way Guide: Designed for quick and accurate drilling when using locking screws. The clavicle plates utilize the MAXLOCK EXTREME locking screw technology. Surgeon has the choice of locking or non-locking screws. There are 4 screw options available: 2.7 mm, 3.5 mm and 4.0 mm non-locking and 3.5 mm locking. The screws have a HEXSTAR drive that can aid in reducing the chance of stripping, a blunt tip to reduce tendon abrasion and a hybrid thread design to maximize purchase and bite. 4
Surgical Technique Step 1: The surgical site is prepared and the fusion or fracture site is reduced and temporarily stabilized by the surgeon s preferred technique. Step 2: Choose an appropriately sized plate based on size and type of indication. The plates are available in various lengths and sizes. Care must be taken not to scratch or notch the implants throughout the procedure. Step 3: If necessary, use the bending irons or bending pliers to contour the plate to the bone surface. When using the bending irons, use your thumbs to apply pressure to the top while pulling apart at the bottom. Use the top slots to place a concave bend in the plate and the bottom slots to place a convex bend in the plate. Each bend should be in one direction only. Reverse or over bending may cause reduced fatigue life. Avoid excessive bending through the locking holes. If the plate is contoured through the locking holes, a non-locking screw is recommended to avoid cross-threading of the locking screw. Note : To bend a lateral clavicle plate, use the bending irons to hold the proximal end while bending the distal end with the bending pliers. Do not insert distal end of the lateral plate into bending irons. Step 4: The plate may be temporarily held in place with standard plate holding forceps, or olive wires (through locking holes or compression slots). 5
Step 5: The screw holes in the plates are compatible with a variety of screw options. Non-locking 2.7 mm, 3.5 mm, and 4.0 mm screws are offered and can be used in either screw hole. 3.5 mm Locking screws are provided for only the threaded locking hole. Screw diameter is chosen based on indication and surgeon preference; a combination of screws may be used in the same plate. Step 6: Four drill bits are provided in the system: 1.9 mm (Gold), 2.4 mm (Magenta) & 2.7 mm (Aqua). The 1.9 mm bit (MFT-072-19) is to be used in conjunction with 2.7 mm screws and the 2.4 mm bit (MFT-072-24) is to be used in conjunction with 3.5 mm screws and the 2.7 mm bit (MFT- 072-27) is to be used in conjunction with 4.0 mm screws. A 4.0 mm (double Aqua ring/mft-072-40) drill bit is also found in the system and can be utilized for lagging all non-locking screw sizes. Step 7: When drilling for non-locking screws, the standard handheld drill guide should be used (MFT-071-24, MFT-071-27, or MFT-071-40). The standard drill guides are color coded to match the appropriate drill bit and screw diameter. When drilling for a locking screw, either the xed drill guide (MFT-071-24-F) or the Key-way Guide (MFT-071-24-KG) should be used. The xed drill guide threads into the locking hole to provide the proper angle for drilling. To use the Key-way Guide, align the lobes on the tip of the guide with the lobes in the threaded hole and press into the plate while drilling to ensure proper alignment. Note : It is necessary to avoid over penetration of the inferior clavicle due to the proximity of the subclavian artery and the brachial plexus. Always use the tissue protector on inferior aspect of clavicle when drilling into bone to protect these structures. 6
Step 8: Drill to desired depth. Take care to not move the plate after drilling for a locking hole in order to maintain the proper pilot hole alignment and prevent locking screw cross-threading. Use only the provided depth gauge to determine screw length. For all screws used throughout procedure, verify screw length in appropriate gauge on screw caddy. Use the driver to insert the screw into the hole and drive the screw. Note : The depth gauge reading corresponds to the working length of the screw (from distal tip to underneath the screw head). It is recommended that the surgeon use fluoroscopy to verify screw length and placement. Step 9: Non-locking screws placed in the compression slots can be used to generate inter-fragmentary compression in the direction of the slot. The direction of the slot is indicated by an arrow. Note : Some plates have compression capabilities in two directions. Always drive compression in the direction the arrow is pointing. Step 10: In order to generate compression, the plate is first xed on the side of the fusion site that the arrow is pointing to using a locking or nonlocking screw with bi-cortical purchase. Step 11: Drill into the slot as far away from the fusion site as possible (opposite of direction the arrow is pointing). 7
Step 12: Insert a non-locking screw bi-cortically using the HEXSTAR driver. Note : If maximum compression is desired it is advised to use a 4.0 screw. Step 13: Tighten the screw into the slot to generate compression. Note : The amount of compression can be modulated from 2 mm (maximum) to 0 mm by drilling into an area of the slot closer to the fusion site. The slot may be utilized with no compression if the non-locking screw is placed in the neutral side of the slot (area of the slot closest to the fusion site). Step 14: Insert any remaining necessary screws. Step 15: When a lag technique is desired, use the 4.0 mm drill bit (double Aqua ring) with the corresponding double ring drill guide to over drill the gliding hole. Note : Be careful to not over drill past the fusion site. Step 16: Do not over torque the screws. Step 17: Correct placement of the fixation device is verified. The soft tissues are replaced as required by the operative procedure and surgeon preferred technique. 8
Implants & Instruments MAXLOCK EXTREME Plates Catalog # Description CLA-002-ANTL Long Anterior Clavicle Plate CLA-002-ANTS Short Anterior Clavicle Plate CLA-002-LATL Standard Left Lateral Clavicle Plate CLA-002-LATR Standard Right Lateral Clavicle Plate CLA-002-LATXL Long Left Lateral Clavicle Plate CLA-002-LATXR Long Right Lateral Clavicle Plate CLA-002-SUP6 Superior Clavicle Plate Drill Bits Catalog # MFT-072-19 MFT-072-24 MFT-072-27 MFT-072-40 Description Ø1.9 mm Standard Drill Bit Ø2.4 mm Standard Drill Bit Ø2.7 mm Standard Drill Bit Ø4.0 mm Standard Drill Bit Wires Catalog # MFT-040 MFT-040-11 Description Olive Wire 1.1 mm K-wire Instruments Catalog # CLA-PRO Description Clavicle Soft Tissue Protector 9
Ø2.7 Non-Locking Screws Catalog # Description MFT-011-27-08 Ø2.7 8 mm Non-locking Screw MFT-011-27-10 Ø2.7 10 mm Non-locking Screw MFT-011-27-12 Ø2.7 12 mm Non-locking Screw MFT-011-27-14 Ø2.7 14 mm Non-locking Screw MFT-011-27-16 Ø2.7 16 mm Non-locking Screw MFT-011-27-18 Ø2.7 18 mm Non-locking Screw MFT-011-27-20 Ø2.7 20 mm Non-locking Screw MFT-011-27-22 Ø2.7 22 mm Non-locking Screw MFT-011-27-24 Ø2.7 24 mm Non-locking Screw MFT-011-27-26 Ø2.7 26 mm Non-locking Screw MFT-011-27-28 Ø2.7 28 mm Non-locking Screw MFT-011-27-30 Ø2.7 30 mm Non-locking Screw Ø3.5 Non-Locking Screws Catalog # Description MFT-011-35-08 Ø3.5 8 mm Non-locking Screw MFT-011-35-10 Ø3.5 10 mm Non-locking Screw MFT-011-35-12 Ø3.5 12 mm Non-locking Screw MFT-011-35-14 Ø3.5 14 mm Non-locking Screw MFT-011-35-16 Ø3.5 16 mm Non-locking Screw MFT-011-35-18 Ø3.5 18 mm Non-locking Screw MFT-011-35-20 Ø3.5 20 mm Non-locking Screw MFT-011-35-22 Ø3.5 22 mm Non-locking Screw MFT-011-35-24 Ø3.5 24 mm Non-locking Screw MFT-011-35-26 Ø3.5 26 mm Non-locking Screw MFT-011-35-28 Ø3.5 28 mm Non-locking Screw MFT-011-35-30 Ø3.5 30 mm Non-locking Screw MFT-011-35-325 Ø3.5 32.5 mm Non-locking Screw MFT-011-35-35 Ø3.5 35 mm Non-locking Screw MFT-011-35-375 Ø3.5 37.5 mm Non-locking Screw MFT-011-35-40 Ø3.5 40 mm Non-locking Screw MFT-011-35-425 Ø3.5 42.5 mm Non-locking Screw MFT-011-35-45 Ø3.5 45 mm Non-locking Screw MFT-011-35-475 Ø3.5 47.5 mm Non-locking Screw MFT-011-35-50 Ø3.5 50 mm Non-locking Screw 10
Ø3.5 Locking Screws Catalog # Description MFT-021-35-08 Ø3.5 8 mm Locking Screw MFT-021-35-10 Ø3.5 10 mm Locking Screw MFT-021-35-12 Ø3.5 12 mm Locking Screw MFT-021-35-14 Ø3.5 14 mm Locking Screw MFT-021-35-16 Ø3.5 16 mm Locking Screw MFT-021-35-18 Ø3.5 18 mm Locking Screw MFT-021-35-20 Ø3.5 20 mm Locking Screw MFT-021-35-22 Ø3.5 22 mm Locking Screw MFT-021-35-24 Ø3.5 24 mm Locking Screw MFT-021-35-26 Ø3.5 26 mm Locking Screw MFT-021-35-28 Ø3.5 28 mm Locking Screw MFT-021-35-30 Ø3.5 30 mm Locking Screw MFT-021-35-325 Ø3.5 32.5 mm Locking Screw MFT-021-35-35 Ø3.5 35 mm Locking Screw MFT-021-35-375 Ø3.5 37.5 mm Locking Screw MFT-021-35-40 Ø3.5 40 mm Locking Screw MFT-021-35-425 Ø3.5 42.5 mm Locking Screw MFT-021-35-45 Ø3.5 45 mm Locking Screw Ø4.0 Non-Locking Screws Catalog # Description MFT-011-40-08 Ø4.0 8 mm Non-locking Screw MFT-011-40-10 Ø4.0 10 mm Non-locking Screw MFT-011-40-12 Ø4.0 12 mm Non-locking Screw MFT-011-40-14 Ø4.0 14 mm Non-locking Screw MFT-011-40-16 Ø4.0 16 mm Non-locking Screw MFT-011-40-18 Ø4.0 18 mm Non-locking Screw MFT-011-40-20 Ø4.0 20 mm Non-locking Screw MFT-011-40-22 Ø4.0 22 mm Non-locking Screw MFT-011-40-24 Ø4.0 24 mm Non-locking Screw MFT-011-40-26 Ø4.0 26 mm Non-locking Screw MFT-011-40-28 Ø4.0 28 mm Non-locking Screw MFT-011-40-30 Ø4.0 30 mm Non-locking Screw MFT-011-40-325 Ø4.0 32.5 mm Non-locking Screw MFT-011-40-35 Ø4.0 35 mm Non-locking Screw MFT-011-40-375 Ø4.0 37.5 mm Non-locking Screw MFT-011-40-40 Ø4.0 40 mm Non-locking Screw MFT-011-40-425 Ø4.0 42.5 mm Non-locking Screw MFT-011-40-45 Ø4.0 45 mm Non-locking Screw MFT-011-40-475 Ø4.0 47.5 mm Non-locking Screw MFT-011-40-50 Ø4.0 50 mm Non-locking Screw MFT-011-40-55 Ø4.0 55 mm Non-locking Screw MFT-011-40-60 Ø4.0 60 mm Non-locking Screw 11
1023 Cherry Road Memphis, TN 38117 800 238 7117 901 867 9971 www.wright.com 10801 Nesbitt Avenue South Bloomington, MN 55437 888 867 6437 952 426 7600 www.tornier.com Proper surgical procedures and techniques are the responsibility of the medical professional. This material is furnished for information purposes only. Each surgeon must evaluate the appropriateness of the material based on his or her personal medical training and experience. Prior to use of any Tornier implant system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications, and adverse effects. Package inserts are also available by contacting Wright. Contact information can be found in this document and the package insert. and denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates. 2016 Wright Medical Group N.V. or its affiliates. All Rights Reserved. MXE-801-012 REV B ECN 160679 15-Jun-2016