NCB Proximal Humerus Surgical Technique System
2016-03-31
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NCB® Proximal Humerus System Surgical Technique 3 NCB® Proximal Humerus System – Surgical Technique Surgical Technique NCB Proximal Humerus System Table of Contents Introduction 4 Cable Fixation Options 5 System Features 7 Indications 9 Contraindications 9 Fracture Classifications 9 Preoperative Planning and Patient Positioning 9 Sample Cases 10 Open Technique (Deltoid Pectoral Incision) Deltoid Pectoral Incision Insertion of the NCB-PH Plate and Fracture Reduction NCB Screw Placement Proximal 3.5 mm Locking Screw Placement (optional) T-Minus Plate (optional) Bone Spacer (optional) Blind Screw Inserts and Sutures (optional) 11 11 13 16 19 21 21 MIS Technique* (High Anterior/Lateral Deltoid Split Incision) High Anterior/Lateral Deltoid Split Incision Targeting Device Insert the NCB-PH Plate NCB Cannulated Screw Placement Implant Removal 22 23 24 25 30 NCB Proximal Humerus – Information Implants 31 Graphic Case for Open Technique 34 Standard Instruments 34 Implants for MIS Surgical Technique 36 Graphic Case for MIS Technique 37 MIS Instruments 38 T-Minus Module (optional) 39 T-Minus Instruments (optional) 40 Planning Aid 41 *MIS Minimally Invasive Solutions™ Technique by Zimmer 4 NCB® Proximal Humerus System – Surgical Technique Introduction NCB Proximal Humerus Osteosynthesis Plate Solution for Proximal Humerus Fractures The NCB-PH (Non-Contact Bridging for the Proximal Humerus) system is an optimal solution for the treatment of complex fractures of the proximal humerus. 7-holes T-minus plate An additional extension T-minus plate can be assembled with cerclage wire technique for fixation of AP lesser tuberosity fractures. 4-, 5- and 7-holes NCB plate The system allows for polyaxial screw placement (30°) with subsequent screw locking for improved stability, especially in osteopenic bone. Before locking, the screws can act as lag screws and be used for fracture reduction, a benefit which is not offered with standard locking systems. In the locked mode the NCB-PH plate acts as an internal fixator without contact between the plate and the bone surface reducing the risk of periosteal blood supply impairment. non contact Polyaxial screw placement with subsequent locking option for optimal system stability. Locking cap 8 mm Non-Contact Bridging ostesynthesis reduces the risk of periosteal blood impairment. Spacer 1 to 3 mm Anatomically contoured plate. Forged titanium alloy for better mechanical strength. Blind screw insert N (Newton) (SD ±6 N) 150 4 Nm Fastening torque Angular stability of one NCB locked screw Materials: NCB plates and screws and 3.5 mm locking screws are made of Ti6Al4V, ISO 5832-3, ASTM F136; the tuberculum minus plate is made of C.P. titanium, ISO 5832-2, ASTM F67. The self tapping cortical screw is made of Ti6Al7Nb, ISO 5832-11, ASTM F1295. Self-tapping screws: 3.5 mm cortical screws L= 20–40 mm 3.5 mm locking screws L= 20–50 mm 4.0 mm NCB screws L= 14–65mm 4.5 mm NCB cancellous screws L= 30–65mm 4.0 mm NCB MotionLoc® screws L= 24–46mm 5 NCB® Proximal Humerus – Surgical Technique Cable Fixation Options The following products from the Zimmer® Cable-Ready® Cable Grip System are compatible with the NCB Proximal Humerus System. See data sheet REF 97-2232-015-00 for more specific instructions. NCB Locking Plate Cable Button, 2.5mm, Hex Drive Hex Button, 3.5mm Cable Assembly Cerclage, 1.8mm • Sterile • Material: Ti6Al4V • Sterile • Material: C.P. Titanium • Sterile • Material: CoCr REF 47-2232-060-00 Color: Gold* REF 47-2232-060-01 Color: Blue REF 00-2232-002-35 REF 00-2232-002-28 REF 00-2232-004-18 Application This Cable Button is threaded directly into the NCB Plate hole to provide a positioning point for the Cable. Instructions To insert, use the 2.5mm hex screwdriver to thread the cable button in to the plate hole. Do not fully tighten to allow the slots in the button to align with the cable. To remove, use 2.5mm hex screwdriver to unthread the cable button from the plate hole. Cable Fixation Options * Not available in Europe, Middle East, and Africa Application This Hex Button fits into the standard hex in the screw head (3.5mm hex). Therefore, it can be inserted into the NCB Screw head or into the NCB Locking Cap. Note: The Hex button is incom patible with the 2.5 mm Hex of the 3.5 mm locking screws (REF 00-2369-0xx-35 and 47-2369-0xx-35) and Cortical, self-tapping screws (REF 02.03131.0xx). Cable Fixation with Cable Button Cable Fixation with Hex Button 6 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique The NCB instrumentation is based on well-known standard surgical techniques and osteosynthesis instruments. The NCB-PH plate can be applied in the MIS* technique using a fully radiolucent targeting device and cannulated cortical and cancellous screws with cannulated instruments. MIS radiolucent targeting device MIS technique with a fully radiolucent targeting device Targeting device and plate assembly 4.0 mm NCB cannulated screw Increased core diameter 3.3 mm Spherical screw head with standard 3.5 mm hexagonal drive Self-drilling and self-tapping screw tip Double lead thread for fast screw insertion for cortical bone 4.5 mm NCB cannulated cancellous screw Cancellous bone thread Fully threaded cancellous screws *MIS Minimally Invasive Solutions™ Technique by Zimmer Cannulation for 1.6 mm Guide Wire NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique System Features Divergent Screw Alignment The targeting device ensures divergent screw alignment for increased pull-out resistance in the metaphyseal and diaphyseal regions. 3.5 mm Locking Screws In order to increase the stabilization of the proximal humeral head, two additional locking screws (i.e. uniaxial locking screws) may be placed in the proximal humeral head. The screws are positioned in convergent manner, in order to increase the pull-out resistance in the humeral head. 7 8 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique Oblique Holes for Sutures Oblique holes 2 mm can be used for sutures after plate osteosynthesis. T-Minus Plate with Cerclage Wire The plate is assembled to the NCB humerus plate with a pre-bent U-shaped cerclage wire 0.8 mm through two holes at the side of the NCB plate. The same plate can be used for left and right. 9 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique Indications Fracture Classifications The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. Indications for Open Technique (Deltoid Pectoral Incision) Note: The NCB Proximal Humerus plate from the NCB Polyaxial Locking Plate System is specifically designed for the proximal humerus. Contraindications • All concomitant diseases that may impair the fixation of the implant and/ or the success of the intervention. • Lack of bone substance or poor bone quality which makes stable seating of the implant impossible. • Acute or chronic, local or systemic infections. • Allergy to the implanted material. • Severe muscular, neural or vascular diseases that endanger the extremities involved. • Neer classification: 2-, 3-, 4-part displaced fractures (anatomical neck, surgical neck, tuberculum majus, tuberculum minus and head splitting). • AO classification: type 11 A, extracapsular, 2 fragments; type 11 B, partially intracapsular, 3 fragments; type 11 C, – intracapsular. Indications for MIS Technique* (Anterior/Lateral Deltoid Split Incision) • Neer classification: 2-part displaced fractures. • AO classification: type 11 A, extracapsular, 2 fragments. Preoperative Planning An X ray of the injured shoulder on the anteroposterior plane is essential for preoperative planning. In addition, a “Y” view, (perpendicular to the anteroposterior view of the scapula is also required). A CT scan can also provide information concerning the tuberosities. The use of the X ray template (REF 06.01511.000) is recommended for preoperative planning. Positioning of the Patient The patient is placed on the operating table in the beachchair position. After the patient is in the correct position, the C-arm must be adjusted so as to achieve the widest possible view of the proximal humerus. Preoperative Planning and Patient Positioning 30°–45° Patient positioning X ray template REF 06.01511.000 10 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique 30° Sample Cases X ray directions Preoperative Postoperative, MIS* operation technique Preoperative Postoperative, open operation technique *MIS Minimally Invasive Solutions™ Technique by Zimmer 11 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique Open Technique Deltoid Pectoral Incision For the open technique the delto-pectoral incision is recommended. Important: Care must be taken to avoid damaging the axillary nerve and blood supply to the bone fragments. Deltoid pectoral incision delto-pectoral Insertion of NCB-PH Plate and Fracture Reduction Due to the anatomical contour, NCB plates may act as a lateral guide for fracture reduction. Insert the NCB-PH plate (REF 02.02262.10x) before fracture reduction. Positioning from A-P view The plate should be placed approx. 10 mm distal to the rotator cuff attachment on the upper edge of the greater tuberosity to avoid postoperative sub acrominal impingement. Positioning from lateral view The plate should be centered against the lateral aspect of the greater tuberosity. Insert the plate before fracture reduction Note: The plate should not be bent, as this might disrupt the function of the locking mechanism. 12 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique First place the distal screw closest to the fracture line (see distal screw placement). Tighten this screw and use the plate for fracture reduction. Insert the distal screw closest to the fracture line Place a 2 mm K-wire (REF 299.20.150) at the proximal end of the plate and use the plate-K-wire construct to secure the reduction. Complete the stabilization of the fracture with the insertion of distal and proximal NCB screws once good fracture reduction has been achieved. Use the plate for fracture reduction 13 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique NCB Screw Placement 1. Screw Angulation 30° screw angulation is possible for all the NCB holes in the plate. The placement of NCB screws depends on the fracture type and the achieved reduction. Alternatively, it is possible to use the cannulated NCB screws. Possible range of screw angulation in NCB plate holes. 2. Screw and Drill Dimensions NCB self-tapping screw and drill dimensions Screw Type Screw Type Cortical Cancellous REF 02.0x155.0xx REF 02.0x159.0xx 4.0 mm 4.5 mm L 14–65 mm L 30–65 mm Drill REF 02.00024.118 3.3 mm Drill REF 103.25.180 2.5 mm Drill guide REF 02.00024.111 3.3 mm Drill guide REF 02.00024.010 2.5 mm NCB MotionLoc Screws Zimmer MotionLoc Screw for NCB Polyaxial Locking Plate System surgical technique (REF 97-3161-002-00 or 97-3161-004-00)* has specific instructions for the NCB MotionLoc Screw. * 97-3161-002-00 is for countries where NCB MotionLoc screws are approved to be used with only NCB plates and 97-3161-004-00 is for countries where NCB MotionLoc screws are approved to be used with both NCB as well as NCB Periprosthetic plates. See NCB MotionLoc package insert for approved plate/MotionLoc screw combinations. 14 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique a) Proximal screw placement When drilling the proximal screw holes, the use of an image intensifier is recom mended. Stop approximately 5 mm before the subchondral bone. 30° For screw placement use the NCB drill guide 2.5 mm (REF 02.00024.010) and the two-fluted drill bit 2.5 mm (REF 103.25.180). The drill guide allows polyaxial screw placement. A stop is felt at 30 degrees. Exact screw setting with the drill guide and drill The screw length is measured with the NCB depth gauge (REF 02.00024.214). The appropriate screw length is chosen from the screw rack. Measuring screw length with the depth gauge Insert the self-tapping screw with the NCB torque screwdriver (REF 02.00024.022). For osteoporotic bone use 4.5 mm NCB cancellous screws. Repeat this procedure to place all proximal bone screws. Note: Hand tighten screws – do not use power. Important: When determing the proximal screw length, the probability of bone resorption and sintering at the fracture site must be taken into account. Care should be taken to ensure that the screw tip is an adequate distance away from the subchondral zone. Insert the self-tapping screw 15 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique b) Distal screw placement Same screw placement procedure as proximally. For screw placement use the NCB drill guide 3.3 mm (REF 02.00024.111) and the NCB drill bit 3.3 mm (REF 02.00024.118). The drill guide allows polyaxial screw placement. A stop is felt at 30 degrees. Insert the screw using the NCB torque screwdriver (REF 02.00024.022). For optimal fixation, bicortical insertion is recommended. Place at least 3 screws below the fracture. Insert the distal self-tapping screws 3. Add Locking Caps To achieve angular stability, insert NCB locking caps (REF 02.0x150.300) for all screws with the NCB torque screwdriver (REF 02.00024.022) until the wrench declutches (clicking sound). Note: Always use the NCB torque screwdriver to tighten the locking caps and make sure not to tilt the screwdriver during its use. Failure to do so could damage the hex drive of the locking cap and might complicate later removal of the implant. Bone spacers can be removed and replaced with screws. M8 locking cap placement, tighten until wrench declutches (click sound) Final placement 16 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique Proximal 3.5 mm Locking Screw Placement (optional) Additionally, after reducing the fracture with NCB screws, it is possible to place 3.5 mm locking screws (REF xx-2369-0xx-35), which are 4° convergent, in the two proximal holes. 1. Screw and Drill Dimensions 3.5mm locking screw and drill dimensions Screw Type Cortical REF xx-2369-0xx-35 3.5 mm L 20–50 mm Drill REF 103.25.180 2.5 mm Drill guide REF 02.00024.223 2.5 mm Tissue protection sleeve REF 02.00024.222 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique 2. Drill Screw Holes Hold the NCB-PH jig (REF 02.00024.220) on the plate and finger tighten or use the small hexagonal screwdriver (REF 109.01.020) to tighten moderatly the NCB-PH connection screw (REF 02.00024.221). Insert the NCB-PH tissue protection sleeve (REF 02.00024.222) and thread the NCB-PH drill guide (REF 02.00024.223) into the plate hole. Then use the two-fluted 2.5 mm drill bit (REF 103.25.180) to drill the screw hole. 17 18 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique 3. Measure Screw Length Remove the two-fluted drill bit 2.5 mm (REF 103.25.180) and the NCB-PH drill guide (REF 02.00024.223) and measure the screw length with the small depth gauge for the 3.5 mm screws (REF 02.00024.216). Important: When determing the proximal screw length, the probability of bone resorption and sintering at the fracture site must be taken into account. Care should be taken to ensure that the screw tip is an adequate distance away from the subchondral zone. 4. Insert the 3.5 mm Locking Screws Insert the appropriate 3.5 mm locking screws (REF xx-2369-0xx-35) using the small hexagonal screwdriver (REF 109.01.020). Once the screw is in place, remove the NCB-PH tissue protection sleeve (REF 02.00024.222) and repeat the procedure if the second locking screw is needed. In order to minimize the risk of failure in the screw head hexagonal, it is recommended to tighten these screws by hand only. 19 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique T-Minus Plate (optional) 1. Apply T-Minus Plate For lesser tuberosity fractures it is possible to apply a small bendable and cuttable plate with 7-holes (REF 02.0x262.101). The plate is fixed to the bone using 3.5 mm standard self-tapping cortical screws (REF 02.03131.0xx). The plate is assembled to the NCB humerus plate with a pre-bent U-shaped cerclage wire 0.8 mm (REF 02.0x362.108) through two holes at the side of the NCB plate. The same plate can be used for the left and right humerus. Apply T-minus plate to the bone 2. Drill Screw Holes Use the standard double drill guide for screws 2.5/3.5/4.0 (REF 100.40.035) and the two-fluted drill bit 2.5 mm, with quick coupling (REF 103.25.180) to drill the holes. Drilling with a standard double-drill guide 3. Measure Screw Length and Place Screws Measure the appropriate screw length with the small depth gauge, for screws 3.5 mm (REF 02.00024.216). Place the 3.5 mm self-tapping cortical screw (REF 02.03131.0xx) with the small hexagonal screwdriver (REF 109.01.020). T-minus plate screw-placement 20 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique 4. Twist the Wire Twist the cerclage wire with wire-bend ing forceps (REF 100.11.155) and apply some tension to the T-minus plate. Standard cerclage wire technique is used 5. Cut the Wire Cut off the remaining cerclage wire with a wire cutter (REF 100.11.115) and bend it along the side of the NCB plate. Cut off the remaining cerclage wire Applied T-minus plate and final construct 21 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique Bone Spacer (optional) You may temporarily insert bone spacers into the locking holes to avoid perios teal blood flow impairment. Insert bone spacer with a 3.5mm hexagonal screwdriver Three. Lengths from 1 to 3 mm are available. Note: The spacers are single-use only. They can be removed after locking the screws. Bone Spacer REF-No Color Length 02.0x150.311 02.0x150.312 02.0x150.313 red blue green 1 mm 2 mm 3 mm Bone spacer 2 mm (blue) proximally and distally Blind Screw Inserts and Sutures (optional) NCB Blind Screw Insertion To prevent bone ingrowth into empty screw holes it is possible to use NCB blind screw inserts (REF 02.0x150.310). Insert the blind screw inserts using a 3.5 mm hexagonal screwdriver. Note: Hand tighten only. NCB blind screw insertion Sutures Oblique holes 2 mm can be used for sutures and reattachment of the rotator cuff after the plate has been fixed to the bone with screws. Oblique holes 2 mm for sutures proximally 22 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique MIS Technique* High Anterior/Lateral Deltoid Split Incision A high anterior/lateral deltoid split incision is recommended. Important: Care must be taken to avoid damaging the axillary nerve and to keep intact the blood supply of the bone fragments. Incision for MIS technique 1. Reduce the Fracture Reduce the fracture and check under image intensification. The humeral head and tuberosity fragments may be manipulated and temporary fixed with 2 mm Kirschner wires (K-wires) (REF 299.20.150). K-wires should be placed where they will not interfere with the plate application. Note: If the use of the additional 3.5 mm locking screws is required, insert these screws after the targeting device is removed. * MIS Minimally Invasive Solutions Technique by Zimmer 23 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique Targeting Device Plate Hole Numbering System To target the correct plate holes there is a numbering system on the targeting module (REF 02.00024.202). Assembly of the targeting device The top side of the targeting module is for the screw holes with numbers: 1–2–4–5–6–7–8–9–10 Turn the targeting module upside down for the number: 3 2 1 3 4 5 6 7 Note: The plate should not be bent since this might compromise the function of the locking mechanism. 8 9 10 NCB screw hole numbering system 24 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique Insert the NCB PH Plate 1. Assemble the MIS* radiolucent targeting device Assemble the radiolucent handle (REF 02.00024.101) to the proximal end of the NCB-PH plate using the NCB-PH connection screw (REF 02.00024.103). Use a 3.5 mm hexagonal screwdriver to tighten the connection screw. 2. Inserting NCB PH Plate Insert the plate (REF 02.02262.10x) through the high anterior/lateral deltoid split incision subcutaneously along the proximal humerus. Insert the plate Note: Attempt to get bone contact immediately. Care must be taken to avoid damaging the axillary nerve and the vascularization of the fragments. 3. Position NCB PH Plate to Bone Positioning from A-P view The plate should be placed approx. 10 mm distal to the rotator cuff attachment on the upper edge of the greater tuberosity to avoid postoperative subacrominal impingement. Plate alignment 10 mm distal of edge greater tuberosity and center against the lateral aspect Positioning from lateral view The plate should be centered against the lateral aspect of the greater tuberosity. 4. Assemble the Targeting Module Attach the targeting module (REF 02.00024.202) to the handle with the hole numbering 1–2–4–5–6–7–8–9–10 on the lateral side. Fit the yellow arrowhead markings. Yellow arrowhead markings Assemble the targeting module *MIS Minimally Invasive Solutions™ Technique by Zimmer 25 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique NCB Cannulated Screw Placement 1. General Remarks Placement of the NCB screws depends on the fracture type and the reduction achieved. Two cannulated screw types are offered with the NCB-PH System. Cancellous NCB screws, preferably for the epiphysis and metaphysis, as well as cortical NCB screws which are optimal for placement in the diaphysis. Both screw types are self-drilling and self-tapping. The screws can be precisely placed over the guide wires. A tissue protection sleeve assembly is used for guidance. A cannulated drill bit can be used to predrill hard cortical bone. Note: Use the cannulated screws only after insertion of 1.6 mm, length 190 mm guide wire (REF 02.01362.116). *MIS Minimally Invasive Solutions™ Technique by Zimmer MIS* Technique NCB Self-Drill Screw and Drill Dimensions Guide wire 02.01362.116 1.6 mm L 190 mm REF Screw Type Screw Type Cannulated Cannulated Cortical, self drilling Cancellous, self drilling REF 02.0x157.0xx REF 02.0x160.0xx 4.0 mm 4.5 mm L 14–65 mm L 30–65 mm Drill REF 02.00024.117 3.3 mm 26 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique 2. Temporary Plate Fixation Proximally, the plate can be temporarily fixed to the bone with a 1.6 mm guide wire through the NCB-PH connection screw (REF 02.00024.103) of the targeting device. To fix the plate distally, insert the NCB Tissue Protection Sleeve assembly 1.6-10 (REF 02.0024.213, 02.0024.114 to 116) through a skin incision and screw the NCB-PH drill guide (REF 02.00024.114) into the plate and then the NCB-PH soft tissue protection sleeve (REF 02.00024.213) into the targeting device. Threaded part to connect to the NCB plate Temporary plate fixation and placement of the tissue protection sleeve Insert 1.6 mm guide wire with a length of 190 mm (REF 02.01362.116) and confirm the correct position with an image intensifier. Insert 1.6 mm guide wire Note: The distal center can be found with 1.6 mm guide wire by finding the anterior and posterior bone cortex and putting the guide wire in the middle of these two reference points. Find the distal center 27 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique 3. Distal Cannulated Screw Placement Determine the screw length from the measurement with the NCB measuring device gauge (REF 02.00024.219) along the 1.6 mm guide wire (L = 190 mm only). Note: With this procedure the distance from the plate to the tip of the measuring device wire is measured. Determine the screw length with the depth gauge For hard cortical bone it is possible to use the 3.3 mm NCB cannulated drill bit (REF 02.00024.117) (only until touching the second cortex, to make sure that the guide wire does not fall out). If the drill bit is used, the screw length can be determined from the scale on the drill bit shaft. Use the cannulated hexagonal screwdriver, hex 3.5 mm (REF 02.00024.120) to insert the cannulated self-drilling screw (REF 02.0x157.0xx) over the 1.6 mm guide wire. Determine the screw length with the scale on the drill bit shaft The NCB screws should be tightened moderately to the bone. Note: For adequate stable fixation, bicortical screw insertion is recommended. Insert the cannulated self-drilling screw 28 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique 4. Achieve Angular Stability To achieve angular stability remove the guide wire and tighten the locking cap (REF 02.0x150.300) with the NCB torque screwdriver (REF 02.00024.022) until the wrench declutches (clicking sound). Note: Always use the NCB torque screwdriver to tighten the locking caps and make sure not to tilt the screwdriver during its usage. Failure to do so could damage the hex drive of the cap and might complicate later extraction of the implant. Tighten the locking caps with the NCB torque screwdriver 5. Proximal Cannulated Screw Placement Insert 1.6 mm guide wire with a length of 190 mm (REF 02.01362.116) close to the subchondral bone and confirm the correct position under image intensifi cation. Insert the guide wire Measure the length with the NCB measuring device (REF 02.00024.219) along the 1.6 mm guide wire (L = 190 mm only). Note: With this procedure the distance from the plate to the tip of the guide wire is measured. Determine the screw length by subtracting a sufficient distance to make sure that the screw is in an adequate distance from the joint. Measuring screw length 29 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique Use the cannulated hexagonal screwdriver, hex 3.5 mm (REF 02.00024.120) to insert the cannulated self-drilling cancellous screw (REF 02.0x160.0xx) over the 1.6 mm guide wire. The NCB screws should only be tightened moderately to the bone. Insert the cannulated self-drilling cancellous screw 6. Achieve Angular Stability To achieve angular stability, remove the guide wire and tighten the locking cap (REF 02.0x150.300) with the NCB torque screwdriver (REF 02.00024.022) until the wrench declutches (clicking sound). Note: Always use the NCB torque screwdriver to tighten the locking caps and make sure not to tilt the screwdriver during its usage. Failure to do so could damage the hex driver of the locking cap and might complicate later extraction of the implant. Tighten the locking caps with the torque screwdriver 30 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique 7. Last Proximal Screw Placement (No. 3) To place the last proximal screw, turn the targeting module over and use hole number 3. Fit the two yellow arrowhead markings together. Then follow the same screw placement procedure as described in step 5–6. Proximal 3.5 mm locking screw placement If the additional stabilization with 3.5 mm locking screws is required, remove the targeting device and repeat the sequence described on page 15. Use of solid screws If fixation with solid screws is preferred, use the NCB-PH MIS drill bit (REF 02.00024.215) and the NCB-PH depth gauge (REF 02.00024.214) to drill and measure the screw length. Turn the targeting module upside down and use the yellow top marking with hole no. 3 No. 3 Implant Removal Position of the targeting module to place screw no. 3 To remove the NCB-PH humerus plate, first remove the 3.5 mm locking screws; if they were used. Then remove all locking caps (REF 02.0x150.300) from the plate. Loosen all bone screws and then remove all bone screws completely. This prevents simultaneous rotation of the plate when removing the last bone screw. 31 NCB NCB®®Proximal ProximalHumerus HumerusSystem – Surgical – Surgical Technique Technique NCB Proximal Humerus – Information NCB® Locking cap 3.9 Implants M 8 x 0.75 mm 8 mm 3.5 Quantity* REF (Non Sterile) REF (Sterile) 10 02.03150.300 02.02150.300 Sterile packed NCB®-PH plate L mm Quantity* 4 80 1 5 93 1 7 117 1 REF (Sterile) Quantity* REF (Non Sterile) REF (Sterile) 02.02262.104 02.02262.105 02.02262.107** 2 02.03150.310 02.02150.310 L NCB® Spacer (red, blue, green) 4.2 Holes NCB® Blind screw M 8 x 0.75 L mm 1 2 3 mm 3.5 3.5 3.5 Quantity* REF (Non Sterile) REF (Sterile) – 2 – 02.03150.311 02.03150.312 02.03150.313 02.02150.311 02.02150.312 02.02150.313 Materials: The NCB plates and screws are made of Ti6Al4V, ISO 5832-3, ASTM F136. *Indicates the quantity of non sterile items in the standard graphic case. ** Not available in all countries. 32 NCB NCB®®Proximal ProximalHumerus Humerus–System Surgical – Surgical Technique Technique NCB® screw, self-tapping NCB® cancellous screw, self-tapping 3.4 4 L L mm mm 14 4 16 4 18 4 20 4 22 4 24 4 26 4 28 4 30 4 32 4 34 4 36 4 38 4 40 4 42 4 44 4 46 4 48 4 50 4 55 4 60 4 65 4 1.75 mm Quantity* REF (Non Sterile) 3.5 – 3.5 – 3.5 – 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 2 3.5 – 3.5 – 3.5 – 3.2 6.2 02.03155.014 02.03155.016 02.03155.018 02.03155.020 02.03155.022 02.03155.024 02.03155.026 02.03155.028 02.03155.030 02.03155.032 02.03155.034 02.03155.036 02.03155.038 02.03155.040 02.03155.042 02.03155.044 02.03155.046 02.03155.048 02.03155.050 02.03155.055 02.03155.060 02.03155.065 4.5 6.2 1.75 L REF (Sterile) L mm mm 02.02155.014 02.02155.016 02.02155.018 02.02155.020 02.02155.022 02.02155.024 02.02155.026 02.02155.028 02.02155.030 02.02155.032 02.02155.034 02.02155.036 02.02155.038 02.02155.040 02.02155.042 02.02155.044 02.02155.046 02.02155.048 02.02155.050 02.02155.055 02.02155.060 02.02155.065 30 4.5 3.5 32 4.5 3.5 34 4.5 3.5 36 4.5 3.5 38 4.5 3.5 40 4.5 3.5 42 4.5 3.5 44 4.5 3.5 46 4.5 3.5 48 4.5 3.5 50 4.5 3.5 55 4.5 3.5 60 4.5 3.5 65 4.5 3.5 Materials: The NCB screws are made of Ti6Al4V, ISO 5832-3, ASTM F136. * Indicates the quantity of Non Sterile implants in the standard graphic case. mm Quantity* REF (Non Sterile) – – – – – – – – 2 2 2 – – – 02.03159.030 02.03159.032 02.03159.034 02.03159.036 02.03159.038 02.03159.040 02.03159.042 02.03159.044 02.03159.046 02.03159.048 02.03159.050 02.03159.055 02.03159.060 02.03159.065 REF (Sterile) 02.02159.030 02.02159.032 02.02159.034 02.02159.036 02.02159.038 02.02159.040 02.02159.042 02.02159.044 02.02159.046 02.02159.048 02.02159.050 02.02159.055 02.02159.060 02.02159.065 33 NCB® Proximal Humerus – Surgical Technique 3.5 mm locking screws (Non Sterile screws are included in the set ZS02.00024.796) 2.74 3.5 NCB® MotionLoc® Screws (optional) 4.0 mm Cortical, Self Tapping. See surgical technique (REF 97-3161-002-00 or 97-3161-004-00)* for more s pecific instructions. 6.2 1.0 ∅4 ∅ 6,2 0.5 L L L mm mm mm Quantity*** REF (Non Sterile) 20 3.5 2.5 2 22 3.5 2.5 2 24 3.5 2.5 2 26 3.5 2.5 2 28 3.5 2.5 2 30 3.5 2.5 2 32 3.5 2.5 2 34 3.5 2.5 2 36 3.5 2.5 2 38 3.5 2.5 2 40 3.5 2.5 2 42 3.5 2.5 2 44 3.5 2.5 2 46 3.5 2.5 2 48 3.5 2.5 2 50 3.5 2.5 2 REF (Sterile) 00-2369-020-35 47-2369-020-35 00-2369-022-35 47-2369-022-35 00-2369-024-35 47-2369-024-35 00-2369-026-35 47-2369-026-35 00-2369-028-35 47-2369-028-35 00-2369-030-35 47-2369-030-35 00-2369-032-35 47-2369-032-35 00-2369-034-35 47-2369-034-35 00-2369-036-35 47-2369-036-35 00-2369-038-35 47-2369-038-35 00-2369-040-35 47-2369-040-35 00-2369-042-35 47-2369-042-35 00-2369-044-35 47-2369-044-35 00-2369-046-35 47-2369-046-35 00-2369-048-35 47-2369-048-35 00-2369-050-35 47-2369-050-35 L mm mm REF (Non Sterile) REF (Sterile) 24 26 28 30 32 34 36 38 40 42 44 46 02.03162.024 02.03162.026 02.03162.028 02.03162.030 02.03162.032 02.03162.034 02.03162.036 02.03162.038 02.03162.040 02.03162.042 02.03162.044 02.03162.046 02.02162.024 02.02162.026 02.02162.028 02.02162.030 02.02162.032 02.02162.034 02.02162.036 02.02162.038 02.02162.040 02.02162.042 02.02162.044 02.02162.046 4.0 4.0 4.0 4.0 4.0 4.0 4.0 4.0 4.0 4.0 4.0 4.0 Compatible Zimmer Products with the NCB Proximal Humerus System REF Sterile Description 47-2232-060-00** 47-2232-060-01 00-2232-002-35 00-2232-002-28 00-2232-004-18 NCB Polyaxial Locking Plate Cable Button, Gold, 2.5mm Hex Drive, Material: Ti6Al4V NCB Polyaxial Locking Plate Cable Button, Blue, 2.5mm Hex Drive, Material: Ti6Al4V Hex Buttons, 3.5mm Hex, Drive Material: C.P. Titanium Cable-Ready Cable Assembly Cerclage, Ø 1.8mm, L. 914mm, Material: CoCr Cable-Ready Cable Assembly Cerclage, Ø 1.8mm, L. 635mm, Material: CoCr Materials: The 3.5 mm locking screws and NCB MotionLoc screws are made of Ti6Al4V, ISO 5832-3, ASTM F136. * 97-3161-002-00 is for countries where NCB MotionLoc screws are approved to be used with only NCB plates and 97-3161-004-00 is for countries where NCB MotionLoc screws are approved to be used with both NCB as well as NCB Periprosthetic plates. See NCB MotionLoc package insert for approved plate/MotionLoc screw combinations. ** Not available in Europe, Middle East and Africa. *** Indicates the quantities of Non Sterile implants in the Ti 3.5 mm locking screw set ZS02.00024.796 34 NCB® Proximal Humerus System – Surgical – Surgical Technique Technique Graphic Case for Open Technique NCB®-PH standard graphic case for open technique (with standard instruments) Unit REF 1 ZS02.00024.760 NCB®-PH graphic case module instruments Quantity* REF 1 02.00024.763 NCB®-PH graphic case module screw rack standard Quantity* REF 1 02.00024.765 NCB®-PH graphic case cover Quantity* REF 1 02.00024.701 NCB®-PH graphic case module implants Quantity* REF 1 02.00024.764 NCB®-PH graphic case insert 1) (empty) Quantity* REF – 02.00024.766 NCB®-PH graphic case base (Inox) Quantity* REF 1 02.00024.702 *Indicates the quantity in the standard graphic case. 1) Optional insert if ordered without MIS instruments. 35 NCB NCB®® Proximal Proximal Humerus Humerus System – Surgical – Surgical Technique Technique Standard Instruments Small depth gauge for 3.5 mm screws Quantity* REF 1 02.00024.216 Small hexagonal screwdriver L mm mm Quantity* REF 245 2.5 1 109.01.020 NCB®-PH torque screwdriver L mm mm Quantity* REF 245 3.5 1 02.00024.022 NCB®-PH jig for 3.5 mm locking screws Quantity* REF 1 02.00024.220 Two-fluted drill bit 2.5 mm L mm Quantity* REF 180 2 103.25.180 NCB® drill bit, with quick coupling L mm mm Quantity* REF 195 3.3 2 02.00024.118 NCB®-PH conn. screw for 02.00024.220 Quantity* REF 2 02.00024.221 Self-holding screw forceps Quantity* REF 1 100.90.005 NCB® locking screw holder for 3.5 mm hexagonal screwdriver L mm Quantity* REF 95 1 02.00024.121 NCB®-PH tissue protection sleeve for 02.00024.220 Quantity* REF 2 02.00024.222 Kirschner wire, with threaded tip L mm mm Quantity* REF 150 2.0 4 299.20.150 NCB®-PH depth gauge Quantity* REF 1 02.00024.214 NCB®-PH drill guide for 02.00024.220 mm Quantity* REF 2.5 2 02.00024.223 NCB® drill guide mm Quantity* REF 2.5 3.3 1 02.00024.010 1 02.00024.111 *Indicates the quantity in the standard graphic case. 36 NCB® Proximal Humerus System – Surgical – Surgical Technique Technique Implants for MIS* Surgical Technique NCB® cannulated screw 4, self-drill NCB® cannulated cancellous screw 4.5, self-drill 3.4 4 3.2 6.2 L 4.5 1.75 6.2 1.75 L L mm mm Quantity** 14 4 – 16 4 – 18 4 – 20 4 2 22 4 2 24 4 2 26 4 2 28 4 2 30 4 2 32 4 2 34 4 2 36 4 2 38 4 2 40 4 2 42 4 2 44 4 2 46 4 2 48 4 2 50 4 2 55 4 – 60 4 – 65 4 – REF (Non Sterile) REF (Sterile) L mm mm 02.03157.014 02.03157.016 02.03157.018 02.03157.020 02.03157.022 02.03157.024 02.03157.026 02.03157.028 02.03157.030 02.03157.032 02.03157.034 02.03157.036 02.03157.038 02.03157.040 02.03157.042 02.03157.044 02.03157.046 02.03157.048 02.03157.050 02.03157.055 02.03157.060 02.03157.065 02.02157.014 02.02157.016 02.02157.018 02.02157.020 02.02157.022 02.02157.024 02.02157.026 02.02157.028 02.02157.030 02.02157.032 02.02157.034 02.02157.036 02.02157.038 02.02157.040 02.02157.042 02.02157.044 02.02157.046 02.02157.048 02.02157.050 02.02157.055 02.02157.060 02.02157.065 30 32 34 36 38 40 42 44 46 48 50 55 60 65 4.5 – 4.5 – 4.5 – 4.5 – 4.5 – 4.5 – 4.5 – 4.5 – 4.5 2 4.5 2 4.5 2 4.5 – 4.5 – 4.5 – Materials: The NCB screws are made of Ti6Al4V, ISO 5832-3, ASTM F136. * MIS Minimally Invasive Solutions Technique by Zimmer ** Indicates the quantity of Non Sterile implants in the MIS graphic case module. Quantity** REF (Non Sterile) REF (Sterile) 02.03160.030 02.03160.032 02.03160.034 02.03160.036 02.03160.038 02.03160.040 02.03160.042 02.03160.044 02.03160.046 02.03160.048 02.03160.050 02.03160.055 02.03160.060 02.03160.065 02.02160.030 02.02160.032 02.02160.034 02.02160.036 02.02160.038 02.02160.040 02.02160.042 02.02160.044 02.02160.046 02.02160.048 02.02160.050 02.02160.055 02.02160.060 02.02160.065 37 NCB® Proximal Humerus System – Surgical Technique Graphic Case for MIS Technique NCB®-PH graphic case module MIS instruments and screw rack (with content) Quantity** REF – ZS02.00024.780 NCB®-PH graphic case module MIS instruments Quantity** REF 1 02.00024.767 NCB®-PH graphic case module MIS screw rack Quantity** REF 1 02.00024.768 **Indicates the quantity in the MIS graphic case module. 38 NCB® Proximal Humerus System – Surgical – Surgical Technique Technique MIS Instruments 1 02.00024.101 NCB® cannulated drill bit with quick coupling L mm mm Quantity** REF 195 3.3 1 02.00024.117 NCB®-PH/PT measuring device for cannulated screws Quantity** REF 1 02.00024.219 NCB®-PH targeting module for targeting device Quantity** REF 1 02.00024.202 NCB®-PH Hexagonal screwdriver cannulated short hex L mm mm Quantity** REF 245 3.5 1 02.00024.120 Cleaning wire 1.6 mm Quantity* REF 1 110.06.200 NCB®-PH connection screw for targeting device Quantity** REF 1 02.00024.103 NCB®-PH MIS drill bit L mm mm Quantity** 230 3.3 1 NCB® PH guide wire with threaded tip L mm mm Quantity** REF 190 1.6 10 02.01362.116 NCB®-PH Quantity** handle for targeting device REF NCB®-PH fixation screw for targeting device Quantity** REF 2 02.00024.104 **Indicates the quantity in the MIS graphic case module. REF 02.00024.215 NCB®-PH tissue protection sleeves Quantity** REF 10/8.0 2 02.00024.213 8/3.3 2 02.00024.114 3.3/1.6 2 02.00024.115 1.6 2 02.00024.116 39 NCB NCB®® Proximal Proximal Humerus Humerus System – Surgical – Surgical Technique Technique T-Minus Module (optional) Implants and instrument set (REF ZS02.00024.790) 17.2 52 Cortical screw, self-tapping 1.2 3.5 2.5 6 1.25 L NCB® T-minus plate, 7 holes Holes Quantity*** REF (Non Sterile) 7 1 02.03262.101 02.02262.101 REF (Sterile) L mm mm 11.5 115 0.8 NCB® Cerclage wire for T-minus plate Stainless Steel L mm mm Quantity*** REF (Non Sterile) 115 0.8 2 Material:The self tapping cortical screw is made of Ti6Al7Nb, ISO 5832-11, ASTM F1295. The tuberculum minus plate is made of C.P. titanium, ISO 5832-2, ASTM F67. *** Indicates the quantity of Non Sterile implants in the T-minus module. mm Quantity*** REF (Non Sterile) 20 3.5 2.5 22 3.5 2.5 24 3.5 2.5 26 3.5 2.5 28 3.5 2.5 30 3.5 2.5 32 3.5 2.5 34 3.5 2.5 36 3.5 2.5 38 3.5 2.5 40 3.5 2.5 REF (Sterile) 02.01362.108 02.00362.108 2 2 2 2 2 2 2 2 2 2 2 02.03131.020 02.03131.022 02.03131.024 02.03131.026 02.03131.028 02.03131.030 02.03131.032 02.03131.034 02.03131.036 02.03131.038 02.03131.040 40 NCB® Proximal Humerus System – Surgical – Surgical Technique Technique T-Minus Instruments (optional) Wire cutter, for wire max. 1.7 mm L mm Quantity*** REF 165 1 100.11.115 Wire bending forceps L mm Quantity*** 140 1 REF 100.11.155 Double drill guides 2.5 / 3.5 / 4.0 Quantity*** REF 1 100.40.035 L l Tap for quick coupling T-handle, with quick coupling for taps Quantity*** REF 1 100.90.210 *** Indicates the quantity in the T-minus module. L mm l mm mm Quantity*** REF 110 50 3.5 1 106.35.110 Countersink, for quick coupling 3.5 and 4.0 mm Quantity*** REF 1 108.01.035 NCB NCB®® Proximal Proximal Humerus Humerus System – Surgical – Surgical Technique Technique Planning Aid X ray template REF 06.01511.000 41 42 NCB® Proximal Humerus System – Surgical – Surgical Technique Technique Notes NCB NCB®® Proximal Proximal Humerus Humerus System – Surgical – Surgical Technique Technique 43 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, indications, contraindications, warnings, precautions, and adverse effects. Contact your Zimmer representative or visit us at www.zimmer.com Lit. No. 06.01499.012 – Ed. 2015-08 ZHUB © 2015 by Zimmer GmbH Printed in Switzerland Subject to change without notice Disclaimer
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