MIS Radiolucent Targeting Device NCB Periprosthetic Femur Plate System Surgical Technique 97 2370 101 00 1
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MIS Radiolucent Targeting Device NCB® Periprosthetic Femur Plate System Surgical Technique 3 NCB® Periprosthetic MIS Radiolucent Targeting Device Table of Contents Introduction 4 Proximal NCB Periprosthetic MIS Technique 6 Insertion of the Proximal NCB Plate 6 Distal NCB Periprosthetic MIS Technique 7 Insertion of the Distal NCB Plate 7 Secure the Safety Lock Pin 8 Reduction of the Metaphyseal Bone Fragments 8 Insertion of the NCB Screws in Diaphyseal Bone 9 Creating Compression between the Plate and the Bone 11 4 NCB® Periprosthetic MIS Radiolucent Targeting Device This surgical technique is intended to be used in conjunction with the NCB Periprosthetic Femur Plate System Surgical Technique (06.02013.012). Introduction Fully radiolucent Targeting Devices are available, allowing MIS techniques to be used for the NCB Periprosthetic Proximal Femur and NCB Periprosthetic Distal Femur Plates. The addition of Bottom Covers provides proper targeting according to plate size by blocking holes that do not correspond to the plate (Fig. 1&2). Each plate length and type has a unique Bottom Cover that targets its hole pattern. NOTE: Use of the Targeting Device prevents polyaxial screw insertion. Fig. 1 Fig. 2 NCB Periprosthetic Femur Plates and NCB MIS Radiolucent Targeting Device with Bottom Covers 5 NCB® Periprosthetic MIS Radiolucent Targeting Device MIS Technique - Targeting Device Assembly for Insertion Thread the Connection Bolt (REF 02.00024.380) through the NCB Periprosthetic Targeting Device (Fig. 3). Attach the Targeting Device by screwing the connection bolt into the NCB Periprosthetic Femur Plate. Attach the NCB Periprosthetic Targeting Device to the corresponding NCB Periprosthetic Plate. (Left Proximal REF 02.00024.371; Left Distal REF 02.00024.373 ; Right Proximal REF 02.00024.370; Right Distal REF 02.00024.372). Screw the Connection Bolt into the NCB Periprosthetic Plate and tighten with the 6Nm Torque Limiting Screwdriver (REF 02.00024.021). Choose the appropriate Bottom Cover (Proximal REF 02.00024.390-394; Distal REF 02.00024.395-399) by matching the plate size with the number of holes indicated on the Bottom Cover for the plate (Fig. 4). Snap it into the bottom of the Targeting Device. Fig. 3 The Connection Bolt is first threaded into the top of the Targeting Device to prevent it from falling out. Proximal Right Left The Bottom Cover is flipped over for right or left application. 21 hole 12 hole Fig. 4 Each plate length and type uses a unique Bottom Cover to match its specific hole pattern. For reference, the 21 hole and 12 hole proximal plates with corresponding bottom covers are shown above. 6 NCB® Periprosthetic MIS Radiolucent Targeting Device Proximal NCB Periprosthetic MIS Technique Make the incision using a lateral subvastus approach. Alternately, incorporate the existing incision if applicable. Avoid excessive stripping of the soft tissue and keep the periosteum intact. Reduce the fracture prior to inserting the plate. Bone fragments can be secured with 2.0mm K-wires (REF 290.20.280) or clamps, such as pointed reduction forceps. Ensure that preliminary fixation devices do not interfere with the future location of the plate and screws, with the prosthesis or with the NCB Periprosthetic Targeting Device. Additional K-wire holes Insertion of the Proximal NCB Plate 1. Insert the plate between the vastus lateralis muscle and the periosteum. Place the Proximal Femur Plate just below the vastus tubercle until you achieve good contact with the bone. Keep the distal end of the plate in close contact with the bone during insertion. Ensure both proximal and distal ends of the plate have good placement on the bone. 2. Make a stab incision at the most distal plate hole. Insert the NCB Trocar (REF 02.00024.062) and Stabilization Bolt (REF 02.00024.074) into the NCB Periprosthetic Plate (Fig. 5). Use the three K-wire holes to hold the targeting device in place, ensuring that the targeting device does not sag. Depending on the patient anatomy, these K-wires may rest on the anterior aspect of the femur when the plate is centered on the bone. NOTE: To place a screw in the distal end of the plate, exchange out the NCB Stabilization Bolt with the NCB Trocar, Drill Guide, and Tissue Protection Sleeve assembly after all other screws have been inserted. Fig. 5 7 NCB® Periprosthetic MIS Radiolucent Targeting Device Distal NCB Periprosthetic MIS Technique A lateral incision is recommended. The skin incision should start at Gerdy’s tubercle and extend proximally. The muscles are left attached to the fracture fragments for optimal blood supply. Do not strip the periosteum. Reduce the fracture prior to inserting the plate. Bone fragments can be secured with 2.0mm K-wires (REF 290.20.280) or clamps, such as pointed reduction forceps. Ensure that preliminary fixation devices do not interfere with the future location of the plate and screws, with the prosthesis or with the NCB Periprosthetic Targeting Device. Additional K-wire holes Insertion of the Distal NCB Plate 1. Insert the plate between the vastus lateralis muscle and the periosteum. Keep the proximal end of the plate in close contact with the bone during insertion. Place the distal end of the plate as distal as possible. Ensure both proximal and distal ends of the plate have good placement on the bone. 2. Make a stab incision at the most proximal plate hole. Insert the NCB Trocar (REF 02.00024.062) and Stabilization Bolt (REF 02.00024.074) into the NCB Periprosthetic Plate (Fig. 6). Use the three K-wire holes to hold the targeting device in place, ensuring that the targeting device does not sag. Depending on the patient anatomy, these K-wires may rest on the anterior aspect of the femur when the plate is centered on the bone. NOTE: To place a screw in the proximal end of the plate, exchange out the NCB Stabilization Bolt with the NCB Trocar, Drill Guide, and Tissue Protection Sleeve assembly after all other screws have been inserted. Fig. 6 8 NCB® Periprosthetic MIS Radiolucent Targeting Device Proximal & Distal NCB Periprosthetic MIS Technique (cont'd) Secure the Safety Lock Pin Insert the NCB Periprosthetic Safety Lock Pin (REF 02.00024.382) into the NCB Periprosthetic Targeting Device from the anterior side to ensure proper distance is maintained between the Targeting Device and the plate throughout the procedure (Fig. 7). To ensure the Pin is locked in place, adjust the distance between the end of the Targeting Device and the end of the plate by gently pushing on the Targeting Device. Reduction of the Metaphyseal Bone Fragments Insert screws into the metaphyseal area of the plate using the open technique on page 20 of the NCB Periprosthetic Femur Plate System Surgical Technique. NOTE: 15o angulation may be restricted when inserting screws in the metaphyseal region with the Targeting Device attached to the plate. NOTE: Some Locking Caps near the metaphyseal region must be placed after the Targeting Device has been removed from the plate. Fig. 7 Adjust the height of the Targeting Device to allow Safety Lock Pin placement. 9 NCB® Periprosthetic MIS Radiolucent Targeting Device Insertion of the NCB Screws in Diaphyseal Bone 1. Make a stab incision to access the plate hole. Insert the NCB Trocar, Drill Guide, and Tissue Protection Sleeve assembly (REF 02.00024.060- 062) (Fig. 8). 2. Screw the Tissue Protection Sleeve into the NCB Periprosthetic Targeting Device. The Tissue Protection Sleeve will be in direct contact with the plate. 3. Screw the Drill Guide into the plate hole. 4. Remove the Trocar. Trocar Drill Guide Fig. 8 Tissue Protection Sleeve 10 NCB® Periprosthetic MIS Radiolucent Targeting Device 5. Insert the correct diameter Drill Bit for the desired screw. The same Drill Guide is used for both the 3.3mm and 4.3mm drill bits. The calibration lines on the Drill Bit can be used to determine the screw length (Fig. 9). Alternatively, determine the screw length using the NCB Depth Gauge (REF 02.00024.006) by measuring through the Drill Guide and Tissue Protection Sleeve (Fig. 10). NOTE: Ensure that other existing medical devices and their fixation and/ or anchorage elements are not affected or damaged by drill bits, taps, or screws. Do not hit the prosthesis with the tip of the drill, tap, or screw. Fig. 9 Fig. 10 11 NCB® Periprosthetic MIS Radiolucent Targeting Device 6. Remove the Drill Guide and insert the appropriate screw using the NCB Hexagonal Screwdriver (REF 02.00024.023) (Fig. 11). NOTE: If the screw is inserted using power, final tightening should be done by hand. Fig. 11 7. To lock the screw, insert a Locking Cap (REF 02.03150.300) and tighten the Cap with the 6Nm Torque Limiting Screwdriver (REF 02.00024.021) until a clicking sound is heard (Fig. 12). NOTE: The Self-Retaining Screwdriver (REF 5912) can be used to prevent screws and Locking Caps from being lost inside the Tissue Protection Sleeve, however the NCB hexagonal screwdriver may be needed to insert the Screw. Final tightening of the Locking Caps must always be done using the 6Nm Torque Limiting Screwdriver. Fig. 12 12 NCB® Periprosthetic MIS Radiolucent Targeting Device 8. Remove the Tissue Protection Sleeve and place a Screw Marker (02.00024.077) into the hole in the NCB Periprosthetic Targeting Device to indicate which plate holes contain screws (Fig. 13). 9. Repeat the above steps as needed to insert additional screws. Fig. 13 (Optional) Creating Compression between the Plate and the Bone 1. Screw the Reduction Spin Knob (REF 00-2360-011-03) onto the threads nearest to the AO adapter on the Plate Reduction Instrument (REF 00-2360-011-01). Plate Reduction Instrument Reduction Spin Knob 2. Insert the NCB Trocar, Drill Guide, and Tissue Protection Sleeve Assembly as described in steps 1-4 from the section entitled "Insertion of the NCB Screws in Diaphyseal Bone" on page 9. 3. Drill the Plate Reduction Instrument into the bone. 4. Turn the Spin Knob against the Drill Guide until it provides the desired amount of compression (Fig. 14). Fig. 14 NCB® Periprosthetic MIS Radiolucent Targeting Device Product Information – MIS Guides and Instruments NCB® Periprosthetic MIS Instruments REF Description 02.00002.001 Assembly Pin 02.00024.003 NCB-PT Drill Bit 4.3MM QC 02.00024.006 NCB-DF Depth Gauge 02.00024.060 NCB-DF Soft Tissue Protection Sleeve 10.0/8.2MM 02.00024.061 NCB-DF Drill Guide 8.2/4.3MM 02.00024.062 NCB-DF Trocar 02.00024.074 NCB-DF Stabilization Bolt 02.00024.077 NCB-PT Screw Marker 02.00024.370 NCB Periprosthetic Femur targeting device, right proximal 02.00024.371 NCB Periprosthetic Femur targeting device, left proximal 02.00024.372 NCB Periprosthetic Femur targeting device, right distal 02.00024.373 NCB Periprosthetic Femur targeting device, left distal 02.00024.380 NCB Periprosthetic Femur connection bolt for targeting device 02.00024.381 NCB Periprosthetic Femur MIS drill bit Ø 3.3mm, with quick coupling 02.02024.381 NCB Periprosthetic Femur MIS drill bit Ø 3.3mm, with quick coupling (sterile) 02.00024.382 NCB Periprosthetic Femur Safety Lock Pin 02.00024.390 NCB Periprosthetic Proximal Femur targeting device bottom cover for 9 hole plate 02.00024.391 NCB Periprosthetic Proximal Femur targeting device bottom cover for 12 hole plate 02.00024.392 NCB Periprosthetic Proximal Femur targeting device bottom cover for 15 hole plate 02.00024.393 NCB Periprosthetic Proximal Femur targeting device bottom cover for 18 hole plate 02.00024.394 NCB Periprosthetic Proximal Femur targeting device bottom cover for 21 hole plate 02.00024.395 NCB Periprosthetic Distal Femur targeting device bottom cover for 9 hole plate 02.00024.396 NCB Periprosthetic Distal Femur targeting device bottom cover for 12 hole plate 02.00024.397 NCB Periprosthetic Distal Femur targeting device bottom cover for 15 hole plate 02.00024.398 NCB Periprosthetic Distal Femur targeting device bottom cover for 18 hole plate 02.00024.399 NCB Periprosthetic Distal Femur targeting device bottom cover for 21 hole plate 00-2360-011-01 Plate Reduction Instrument 00-2360-011-03 Reduction Spin Knob 5912 Self-Retaining Screwdriver Graphic Cases for NCB Periprosthetic MIS Instruments Standard Graphic Cases REF Description 02.00024.913 NCB Periprosthetic Femur MIS Case Assembly 02.00024.914 NCB Periprosthetic Femur MIS Case Base 02.00024.915 NCB Periprosthetic Femur MIS Case Tray 00-5900-099-00 Generic Lid 13 This documentation is intended exclusively for physicians and is not intended for laypersons. Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information, including, but not limited to, contraindications, warnings, precautions, and adverse effects. Contact your Zimmer representative or visit us at www.zimmer.com The CE mark is valid only if it is also printed on the product label. 97-2370-010-00 7-24-13 Printed in USA ©2013 Zimmer, Inc.
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/;/metadata, /;/metadata, /metadata, /;/metadata, /;/metadata Metadata Date : 2015:12:02 10:16:15-05:00 Creator Tool : Adobe InDesign CS5 (7.0.4) Page Image Page Number : 1, 2 Page Image Format : JPEG, JPEG Page Image Width : 256, 256 Page Image Height : 256, 256 Page Image : (Binary data 9334 bytes, use -b option to extract), (Binary data 3548 bytes, use -b option to extract) Doc Change Count : 6 Key Stamp Mp : AAAAAA== Format : application/pdf Title : MIS Radiolucent Targeting Device NCB Periprosthetic Femur Plate System Surgical Technique 97-2370-101-00 Description : MIS Radiolucent Targeting Device NCB Periprosthetic Femur Plate System Surgical Technique Creator : Zimmer, Inc. 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