6.58.0 Cannulated Screw System Surgical Technique 1
2016-05-20
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Biomet 6.5 / 8.0 mm Cannulated Screw System Surgical Technique One Surgeon. One Patient. Over 1 million times per year, Biomet helps one surgeon provide personalized care to one patient. The science and art of medical care is to provide the right solution for each individual patient. This requires clinical mastery, a human connection between the surgeon and the patient, and the right tools for each situation. At Biomet, we strive to view our work through the eyes of one surgeon and one patient. We treat every solution we provide as if it’s meant for a family member. Our approach to innovation creates real solutions that assist each surgeon in the delivery of durable personalized care to each patient, whether that solution requires a minimally invasive surgical technique, advanced biomaterials or a patient-matched implant. When one surgeon connects with one patient to provide personalized care, the promise of medicine is fulfilled. 6.5/ 8.0 mm Cannulated Screw System Biomet 6.5/8.0 mm Cannulated Screw System The Biomet 6.5/ 8.0 mm Cannulated Screw System is part of a series of systems developed by Biomet for cannulated screws ranging from 4.0 to 8.0 mm. Matching a combination of screw options with necessary instrumentation, the systems provide convenience and flexibility for the orthopaedic surgeon and the OR staff. Consistent with all Biomet Trauma implants, the screws offer TiMAX benefits of increased fatigue strength compared to unanodized Ti and 316L stainless steel.1 Guide wire diameters have also been reduced allowing screw purchase. The stiffness of the guide wire has not been compromised because they are manufactured out of cobalt chrome. These systems are truly designed with the surgeon in mind. 3 6.5/ 8.0 mm Cannulated Screw System Subtalar Arthrodesis: 6.5 mm Cannulated Screw Surgical Technique Figure 1 Figure 2 Guide Wire Insertion Countersinking and Measurement Position the guide wire end of the 2.8 /4.8 mm Drill Guide (Cat. No. 110008428) at the entry point and insert a 2.8 mm Guide Wire (Cat. No. 110008397) to the desired depth and verify with fluoroscopy (Figure 1). The drill end of the drill guide can be positioned over the entry point if the drill will be utilized through the drill guide. Remove the drill guide and insert the 6.5/8.0 mm Depth Gauge with Countersink (Cat. No. 110008465) over the inserted guide wire. Using the handle, rotate the depth gauge back and forth until sufficient countersinking has been achieved, and note the screw length measurement on the calibrated gauge (Figure 2). Note: To prevent excessive bone removal, countersinking under power is not recommended. 4 Figure 3 Figure 4 Pre-Drilling Screw Insertion Connect the 4.8 mm Cannulated Drill (Cat. No. 110008408) to a power adapter and slide the drill over the guide wire. Drill to appropriate depth and remove drill, leaving the guide wire in place (Figure 3). Advance the selected 6.5 mm screw over the guide wire using the BT30 Cannulated Hexolobular Screwdriver (Cat. No. 110008455) attached to the Screwdriver Handle (Cat. No. 110017412) until the head of the screw is completely seated in the bone (Figure 4). A flat washer may be used in conjunction with the same screw diameter size for osteoporotic bone or where the cortex is thin, increasing the surface area of the screw head. 6.5 mm Flat Washer (Cat. No. 110008351) 8.0 mm Flat Washer (Cat. No. 110008353) Note: Screw removal or additional adjustment when not using a guide wire in the cannulation of the screw can be achieved by utilizing the BT30 SOLID Hexolobular Screwdriver (Cat. No. 110009967). 5 6.5/ 8.0 mm Cannulated Screw System Open Technique for Hip Fracture Figure 1 Patient Preparation Note: For the purposes of this technique, we will discuss only the technique and instrumentation as it relates to the 8.0 mm cannulated screw. However, the 6.5 mm cannulated screw may also be used in hip fracture applications. The patient is placed in the supine position on a standard fracture table (Figure 1). The patient may be given a general or spinal anesthetic prior to fracture reduction. The fracture is reduced by gentle traction with the leg slightly rotated externally. The leg is then gently rotated at the knee approximately 45-60° internally. AP and lateral projections on image intensification should be used to ensure accurate reduction of the fracture. On reduction there should be no varus angulation, no more than 15° valgus angulation and no more than 10° of anterior or posterior angulation. Once reduction is achieved the lateral aspect of the hip is prepared and draped in the usual manner using sterile technique. 6 135° Figure 2 Figure 3 Surgical Exposure Placement of the Guide Pins A guide pin placed externally on the anterior surface of the hip may be used as a template to determine the appropriate location for the incision. When viewed under image intensification this “template” guide pin should lay adjacent to the inferior aspect of the femoral neck advancing into the femoral head. A guide pin is placed on the anterior aspect of the femoral neck to act as a template. Image intensification is used to verify its correct orientation adjacent to the inferior cortex at an angle of 135° to the femoral shaft (Figure 3). A 5 cm incision is made over the lateral aspect of the hip extending from the flare of the greater trochanter distally. The incision is carried sharply down through the skin and subcutaneous tissue to the vastus lateralis. The vastus lateralis is retracted laterally and split. Muscle tissue is stripped free from the femur and a Bennett retractor is placed around the femoral shaft exposing its lateral aspect (Figure 2). A 2.8 mm Guide Wire (Cat. No. 110008397 or 110008399) is drilled under power into the lateral cortex in the mid shaft of the femur parallel to the template guide pin. The guide wire is advanced adjacent to the inferior cortex at an angle of 135° to the femoral shaft. The 2.8 mm Parallel Wire Guide (Cat. No. 110008441) can be used through the Outer Sheath with Handle (Cat. No. 110008434) as a guide through soft tissue if needed. 7 6.5/ 8.0 mm Cannulated Screw System 135° Figure 4 Figure 5 Placement of the Guide Pins (cont.) The correct position of the guide wire is confirmed under image intensification. Both AP and lateral images should be used to confirm that the guide wire is advancing towards the center of the femoral head. Once this has been determined, the guide wire is passed across the fracture site into the femoral head to within 1 cm of subchondral bone (Figure 4). 8 The guide pin should be tapped into its final position at an angle of 135° to the femoral shaft, adjacent to the inferior cortex of the femoral neck with its tip within 5 mm of subchondral bone (Figure 5). Figure 6 Both AP and lateral images should be used to confirm that the guide pin is appropriately placed and has not been bent during insertion (Figure 6). Note: The position of the first guide pin adjacent to the inferior cortex is important as the cannulated screw that is placed in this position acts as a buttress to support the femoral head, reducing the potential for varus deformity. Figure 7 The Parallel Drill Guide (Cat. No. 110008441) is positioned on the femoral shaft by sliding the most distal hole over the first guide pin. The drill guide confirms the angle of the first guide pin and facilitates parallel placement of the following guide pins (Figure 7). 9 6.5/ 8.0 mm Cannulated Screw System Figure 8a Figure 8 Figure 9 Placement of the Guide Pins (cont.) The anterior and posterior guide pins are positioned in the appropriate holes in the drill guide and advanced into the femoral head to within 5 mm of subchondral bone (Figure 8). When all of the guide pins are placed, the inferior pin should lay adjacent to the inferior cortex and the tips of the other pin(s) should be within 5 mm of subchondral bone (Figure 9). Note: If three screws are indicated, only an outer three hole triangle pattern may be used with the parallel drill guide due to the large diameter of this screw (Figure 8a). Under image intensification the guide pins should not appear bent nor be in contact with one another. Caution: Perforation of the femoral head with a guide pin must be avoided. Once a guide pin penetrates the joint space and a cannulated screw is inserted over the guide pin, there is a possibility that the cannulated screw will follow the path of the original guide pin and penetrate the joint space. A guide pin that has penetrated the joint space must be removed completely and be reinserted in a different position. 10 Figure 10 Figure 11 Measurement Cannulated Screw Insertion After correct placement of the guide pins within 5 mm of subchondral bone, the drill guide is removed and the guide pin Depth Gauge with Countersink (Cat. No. 110008465) is placed over each guide pin and advanced to the femoral cortex. If countersinking is desired, the depth gauge may be turned back and forth until the bone has been sufficiently countersunk. The length of the screw is then read directly off the gauge at the end of the guide wire (Figure 10). The appropriate length cannulated screw is placed over the guide wire and inserted either with power using the screwdriver shank (Cat. No. 110008455) attached to a power adapter, or manually with the screwdriver shank attached to the Screwdriver Handle (Cat. No. 110017412). The T-Handle (Cat. No. 14-451560) can be used for additional torque if needed (Figure 11). Note: The position of the guide wire must be frequently checked under image during screw insertion to ensure that the guide pin is not advancing with the screw. The inferior screw adjacent to the inferior cortex is advanced first until the head of the screw is within 1 cm of the lateral cortex. The remaining screw(s) are then also inserted and advanced to within 1 cm of the lateral cortex. 11 6.5/ 8.0 mm Cannulated Screw System Figure 12 Final Tightening In order to prevent varus angulation, the anterior and posterior screws should be tightened before the inferior screw. The screws should be advanced alternately several turns at a time until they are completely seated tight. The inferior screw is then tightened. Final seating of the screw should always be performed manually, one half turn at a time, alternating sequentially between each of the three until the head of each screw has made solid contact with the lateral cortex (Figure 12). 12 Once correct placement of the screws and reduction of the fracture has been confirmed under image intensification, traction is released and the hip is rotated through the full range of motion. This is performed while viewing the AP and lateral image to assure that there has been no penetration of the joint space. The wound is then thoroughly irrigated and closed in the usual manner. Figure 13 Screw Removal Screw removal should always be started manually. Once started, screws may be removed either with power using the BT30 Solid Screwdriver shank (Cat. No. 110009967) attached to the power adapter, or manually with the screwdriver shank attached to the screwdriver handle, or the T-Handle. Caution: Under no circumstances should pliers or similar devices be used to grip the screw head as this will damage the screw and could lead to breakage. If the cannulated screw becomes damaged or removal becomes difficult, the Easy Out (Cat. No. 110008495) should be used for screw extraction. The Easy Out must be used manually in conjunction with the T-Handle. The tip of the Easy Out is inserted through the head and down the center of the cannulated screw. The Easy Out is turned counter-clockwise while applying firm forward pressure. The Easy Out cuts into the cannula of the screw shaft to facilitate removal. The Easy Out extractor may be used even if the head or shaft of the screw is not intact (Figure 13). 13 6.5/ 8.0 mm Cannulated Screw System Ancillary Components Equipment Maintenance Washers are available for use in osteoporotic bone. Special care should be exercised during the cleaning of cannulated instrumentation to ensure that all foreign material is removed from the inside of the instrument. Regular inspection and careful maintenance will increase the useful life of all instrumentation. SCREW WASHER NON-STERILE STERILE 6.5 mm 6.5 mm 110008351 110008363 8.0 mm 8.0 mm 110008353 110008364 Caution Guide wires should be replaced after each surgery. Use of scored or bent guide wires increases the risk of unwanted guide wire advancement or breakage during screw insertion. During cannulated screw insertion the surgeon must periodically check for undesired advancement of the guide wire. The text and schematic drawings included in this protocol are general instructions for the use of Biomet instrumentation only. Placement of screws and plates for the stabilization of specific fractures must be determined using the best judgment of the surgeon. 14 Implants 6.5 mm Cannulated Screws (16 mm thread) NON-STERILE NO. STERILE NO. DESCRIPTION RECOMMENDED QTY 110007733 110007735 110007737 110007739 110007741 110007743 110007745 110007747 110007749 110007751 110007753 110007755 110007757 110007759 110007761 110007763 110007765 110007767 110007769 110007771 110007773 – – – – – – – – – – 110009929 110009930 110009931 110009932 110009933 110009934 110009935 110009936 110009937 110009938 110009939 110009940 110009941 110009942 110009943 110009944 110009945 110009946 110009947 110009948 110009949 110009950 110007775 110009952 110007777 110009954 110007779 110009956 110007781 110009958 110007783 Cann Screw 6.5 x 30 mm 16 mm Thd Cann Screw 6.5 x 35 mm 16 mm Thd Cann Screw 6.5 x 40 mm 16 mm Thd Cann Screw 6.5 x 45 mm 16 mm Thd Cann Screw 6.5 x 50 mm 16 mm Thd Cann Screw 6.5 x 55 mm 16 mm Thd Cann Screw 6.5 x 60 mm 16 mm Thd Cann Screw 6.5 x 65 mm 16 mm Thd Cann Screw 6.5 x 70 mm 16 mm Thd Cann Screw 6.5 x 75 mm 16 mm Thd Cann Screw 6.5 x 80 mm 16 mm Thd Cann Screw 6.5 x 85 mm 16 mm Thd Cann Screw 6.5 x 90 mm 16 mm Thd Cann Screw 6.5 x 95 mm 16 mm Thd Cann Screw 6.5 x 100 mm 16 mm Thd Cann Screw 6.5 x 105 mm 16 mm Thd Cann Screw 6.5 x 110 mm 16 mm Thd Cann Screw 6.5 x 115 mm 16 mm Thd Cann Screw 6.5 x 120 mm 16 mm Thd Cann Screw 6.5 x 125 mm 16 mm Thd Cann Screw 6.5 x 130 mm 16 mm Thd Cann Screw 6.5 x 135 mm 16 mm Thd Cann Screw 6.5 x 140 mm 16 mm Thd Cann Screw 6.5 x 145 mm 16 mm Thd Cann Screw 6.5 x 150 mm 16 mm Thd Cann Screw 6.5 x 155 mm 16 mm Thd Cann Screw 6.5 x 160 mm 16 mm Thd Cann Screw 6.5 x 165 mm 16 mm Thd Cann Screw 6.5 x 170 mm 16 mm Thd Cann Screw 6.5 x 175 mm 16 mm Thd Cann Screw 6.5 x 180 mm 16 mm Thd 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 2 2 2 2 2 2 0 0 0 0 0 0 0 0 0 0 Reference IFU 01-50-4048 for screw and washer product information. 15 6.5/ 8.0 mm Cannulated Screw System 6.5 mm Cannulated Screws (40 mm thread) NON-STERILE NO. STERILE NO. DESCRIPTION RECOMMENDED QTY 110007803 110007805 110007807 110007809 110007811 110007813 110007815 110007817 110007819 110007821 110007823 110007825 110007827 – – – – – – – – – – 110009969 110009970 110009971 110009972 110009973 110009974 110009975 110009976 110009977 110009978 110009979 110009980 110009981 110009982 110007829 110009984 110007831 110009986 110007833 110009988 110007835 110009990 110007837 Cann Screw 6.5 x 70 mm 40 mm Thd Cann Screw 6.5 x 75 mm 40 mm Thd Cann Screw 6.5 x 80 mm 40 mm Thd Cann Screw 6.5 x 85 mm 40 mm Thd Cann Screw 6.5 x 90 mm 40 mm Thd Cann Screw 6.5 x 95 mm 40 mm Thd Cann Screw 6.5 x 100 mm 40 mm Thd Cann Screw 6.5 x 105 mm 40 mm Thd Cann Screw 6.5 x 110 mm 40 mm Thd Cann Screw 6.5 x 115 mm 40 mm Thd Cann Screw 6.5 x 120 mm 40 mm Thd Cann Screw 6.5 x 125 mm 40 mm Thd Cann Screw 6.5 x 130 mm 40 mm Thd Cann Screw 6.5 x 135 mm 40 mm Thd Cann Screw 6.5 x 140 mm 40 mm Thd Cann Screw 6.5 x 145 mm 40 mm Thd Cann Screw 6.5 x 150 mm 40 mm Thd Cann Screw 6.5 x 155 mm 40 mm Thd Cann Screw 6.5 x 160 mm 40 mm Thd Cann Screw 6.5 x 165 mm 40 mm Thd Cann Screw 6.5 x 170 mm 40 mm Thd Cann Screw 6.5 x 175 mm 40 mm Thd Cann Screw 6.5 x 180 mm 40 mm Thd 2 2 2 2 2 2 2 2 2 2 2 2 2 0 0 0 0 0 0 0 0 0 0 Reference IFU 01-50-4048 for screw and washer product information. 16 6.5 mm Cannulated Screws (full thread) NON-STERILE NO. STERILE NO. DESCRIPTION RECOMMENDED QTY 110007841 110007843 110007845 110007847 110007849 110007851 110007853 110007855 110007857 110007859 110007861 110007863 110007865 110007867 110007869 110007871 110007873 110007875 110007877 110007879 110007881 – – – – – – – – – – 110009993 110009994 110009995 110009996 110009997 110009998 110009999 110010000 110010001 110010002 110010003 110010004 110010005 110010006 110010007 110010008 110010009 110010010 110010011 110010012 110010013 110010014 110007883 110010016 110007885 110010018 110007887 110010020 110007889 110010022 110007891 Cann Screw 6.5 x 30 mm Full Thd Cann Screw 6.5 x 35 mm Full Thd Cann Screw 6.5 x 40 mm Full Thd Cann Screw 6.5 x 45 mm Full Thd Cann Screw 6.5 x 50 mm Full Thd Cann Screw 6.5 x 55 mm Full Thd Cann Screw 6.5 x 60 mm Full Thd Cann Screw 6.5 x 65 mm Full Thd Cann Screw 6.5 x 70 mm Full Thd Cann Screw 6.5 x 75 mm Full Thd Cann Screw 6.5 x 80 mm Full Thd Cann Screw 6.5 x 85 mm Full Thd Cann Screw 6.5 x 90 mm Full Thd Cann Screw 6.5 x 95 mm Full Thd Cann Screw 6.5 x 100 mm Full Thd Cann Screw 6.5 x 105 mm Full Thd Cann Screw 6.5 x 110 mm Full Thd Cann Screw 6.5 x 115 mm Full Thd Cann Screw 6.5 x 120 mm Full Thd Cann Screw 6.5 x 125 mm Full Thd Cann Screw 6.5 x 130 mm Full Thd Cann Screw 6.5 x 135 mm Full Thd Cann Screw 6.5 x 140 mm Full Thd Cann Screw 6.5 x 145 mm Full Thd Cann Screw 6.5 x 150 mm Full Thd Cann Screw 6.5 x 155 mm Full Thd Cann Screw 6.5 x 160 mm Full Thd Cann Screw 6.5 x 165 mm Full Thd Cann Screw 6.5 x 170 mm Full Thd Cann Screw 6.5 x 175 mm Full Thd Cann Screw 6.5 x 180 mm Full Thd 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 0 0 0 0 0 0 0 0 0 0 Reference IFU 01-50-4048 for screw and washer product information. 17 6.5/ 8.0 mm Cannulated Screw System 8.0 mm Cannulated Screws (16 mm thread) NON-STERILE NO. STERILE NO. DESCRIPTION RECOMMENDED QTY 110007894 110007896 110007898 110007900 110007902 110007904 110007906 110007908 110007910 110007912 110007914 110007916 110007918 110007920 110007922 110007924 110007926 110007928 110007930 110007932 110007934 – – – – – – – – – – 110010025 110010026 110010027 110010028 110010029 110010030 110010031 110010032 110010033 110010034 110010035 110010036 110010037 110010038 110010039 110010040 110010041 110010042 110010043 110010044 110010045 110010046 110007936 110010048 110007938 110010050 110007940 110010052 110007942 110010054 110007944 Cann Screw 8.0 x 30 mm 16 mm Thd Cann Screw 8.0 x 35 mm 16 mm Thd Cann Screw 8.0 x 40 mm 16 mm Thd Cann Screw 8.0 x 45 mm 16 mm Thd Cann Screw 8.0 x 50 mm 16 mm Thd Cann Screw 8.0 x 55 mm 16 mm Thd Cann Screw 8.0 x 60 mm 16 mm Thd Cann Screw 8.0 x 65 mm 16 mm Thd Cann Screw 8.0 x 70 mm 16 mm Thd Cann Screw 8.0 x 75 mm 16 mm Thd Cann Screw 8.0 x 80 mm 16 mm Thd Cann Screw 8.0 x 85 mm 16 mm Thd Cann Screw 8.0 x 90 mm 16 mm Thd Cann Screw 8.0 x 95 mm 16 mm Thd Cann Screw 8.0 x 100 mm 16 mm Thd Cann Screw 8.0 x 105 mm 16 mm Thd Cann Screw 8.0 x 110 mm 16 mm Thd Cann Screw 8.0 x 115 mm 16 mm Thd Cann Screw 8.0 x 120 mm 16 mm Thd Cann Screw 8.0 x 125 mm 16 mm Thd Cann Screw 8.0 x 130 mm 16 mm Thd Cann Screw 8.0 x 135 mm 16 mm Thd Cann Screw 8.0 x 140 mm 16 mm Thd Cann Screw 8.0 x 145 mm 16 mm Thd Cann Screw 8.0 x 150 mm 16 mm Thd Cann Screw 8.0 x 155 mm 16 mm Thd Cann Screw 8.0 x 160 mm 16 mm Thd Cann Screw 8.0 x 165 mm 16 mm Thd Cann Screw 8.0 x 170 mm 16 mm Thd Cann Screw 8.0 x 175 mm 16 mm Thd Cann Screw 8.0 x 180 mm 16 mm Thd 0 0 2 2 2 2 2 2 3 3 3 3 3 3 3 2 2 2 2 2 2 0 0 0 0 0 0 0 0 0 0 Reference IFU 01-50-4048 for screw and washer product information. 18 8.0 mm Cannulated Screws (40 mm thread) NON-STERILE NO. STERILE NO. DESCRIPTION RECOMMENDED QTY 110007962 110007964 110007966 110007968 110007970 110007972 110007974 110007976 110007978 110007980 110007982 110007984 110007986 – – – – – – – – – – 110010065 110010066 110010067 110010068 110010069 110010070 110010071 110010072 110010073 110010074 110010075 110010076 110010077 110010078 110007988 110010080 110007990 110010082 110007992 110010084 110007994 110010086 110007996 Cann Screw 8.0 x 70 mm 40 mm Thd Cann Screw 8.0 x 75 mm 40 mm Thd Cann Screw 8.0 x 80 mm 40 mm Thd Cann Screw 8.0 x 85 mm 40 mm Thd Cann Screw 8.0 x 90 mm 40 mm Thd Cann Screw 8.0 x 95 mm 40 mm Thd Cann Screw 8.0 x 100 mm 40 mm Thd Cann Screw 8.0 x 105 mm 40 mm Thd Cann Screw 8.0 x 110 mm 40 mm Thd Cann Screw 8.0 x 115 mm 40 mm Thd Cann Screw 8.0 x 120 mm 40 mm Thd Cann Screw 8.0 x 125 mm 40 mm Thd Cann Screw 8.0 x 130 mm 40 mm Thd Cann Screw 8.0 x 135 mm 40 mm Thd Cann Screw 8.0 x 140 mm 40 mm Thd Cann Screw 8.0 x 145 mm 40 mm Thd Cann Screw 8.0 x 150 mm 40 mm Thd Cann Screw 8.0 x 155 mm 40 mm Thd Cann Screw 8.0 x 160 mm 40 mm Thd Cann Screw 8.0 x 165 mm 40 mm Thd Cann Screw 8.0 x 170 mm 40 mm Thd Cann Screw 8.0 x 175 mm 40 mm Thd Cann Screw 8.0 x 180 mm 40 mm Thd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Reference IFU 01-50-4048 for screw and washer product information. 19 6.5/ 8.0 mm Cannulated Screw System 8.0 mm Cannulated Screws (full thread) NON-STERILE NO. STERILE NO. DESCRIPTION RECOMMENDED QTY 110007998 110008000 110008002 110008004 110008006 110008008 110008010 110008012 110008014 110008016 110008018 110008020 110008022 110008024 110008026 110008028 110008030 110008032 110008034 110008036 110008038 – – – – – – – – – – 110010089 110010090 110010091 110010092 110010093 110010094 110010095 110010096 110010097 110010098 110010099 110010100 110010101 110010102 110010103 110010104 110010105 110010106 110010107 110010108 110010109 110010110 110008040 110010112 110008042 110010114 110008044 110010116 110008046 110010118 110008048 Cann Screw 8.0 x 30 mm Full Thd Cann Screw 8.0 x 35 mm Full Thd Cann Screw 8.0 x 40 mm Full Thd Cann Screw 8.0 x 45 mm Full Thd Cann Screw 8.0 x 50 mm Full Thd Cann Screw 8.0 x 55 mm Full Thd Cann Screw 8.0 x 60 mm Full Thd Cann Screw 8.0 x 65 mm Full Thd Cann Screw 8.0 x 70 mm Full Thd Cann Screw 8.0 x 75 mm Full Thd Cann Screw 8.0 x 80 mm Full Thd Cann Screw 8.0 x 85 mm Full Thd Cann Screw 8.0 x 90 mm Full Thd Cann Screw 8.0 x 95 mm Full Thd Cann Screw 8.0 x 100 mm Full Thd Cann Screw 8.0 x 105 mm Full Thd Cann Screw 8.0 x 110 mm Full Thd Cann Screw 8.0 x 115 mm Full Thd Cann Screw 8.0 x 120 mm Full Thd Cann Screw 8.0 x 125 mm Full Thd Cann Screw 8.0 x 130 mm Full Thd Cann Screw 8.0 x 135 mm Full Thd Cann Screw 8.0 x 140 mm Full Thd Cann Screw 8.0 x 145 mm Full Thd Cann Screw 8.0 x 150 mm Full Thd Cann Screw 8.0 x 155 mm Full Thd Cann Screw 8.0 x 160 mm Full Thd Cann Screw 8.0 x 165 mm Full Thd Cann Screw 8.0 x 170 mm Full Thd Cann Screw 8.0 x 175 mm Full Thd Cann Screw 8.0 x 180 mm Full Thd 0 0 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 0 0 0 0 0 0 0 0 0 0 NON-STERILE NO. STERILE NO. DESCRIPTION RECOMMENDED QTY 110008351 110008353 110008363 110008364 Flat Washer 6.5 mm Flat Washer 8.0 mm 3 3 Washers Reference IFU 01-50-4048 for screw and washer product information. 20 Disposables NON-STERILE NO. STERILE NO. DESCRIPTION RECOMMENDED QTY – – – – 110008397 110008399 110008408 110008410 2.8 x 300 mm Guide Pin Drill Tip 2.8 x 450 mm Guide Pin Drill Tip 4.8 x 200 mm Cann Drill w/ ZH 4.8 x 300 mm Cann Drill w/ ZH 2 1 2 2 Instruments NON-STERILE NO. STERILE NO. DESCRIPTION RECOMMENDED QTY 110008428 110008455 110009967 110008465 110008434 110008441 110008484 110017410 110017412 14-451560 13571 110008496 – – – – – – – – – – – – 2.8 / 4.8 mm Drill Guide BT30 Cann Hexalobular Driver ZH BT30 Solid Hexalobular Driver ZH 6.5 / 8.0 mm Depth Gauge w/ Countersink Outer Sheath w/ Handle Parallel Wire Guide 2.8 mm Offset Delta Wire Guide 2.8 mm Standard Ratchet Handle ZH T Ratchet Handle ZH Guide Wire Pusher 2.8 mm Screw Forceps Easy Out Small Tip 1 2 1 1 1 1 1 1 1 1 1 1 NON-STERILE NO. STERILE NO. DESCRIPTION RECOMMENDED QTY 110008481 – Cann Screw Case 6.5 / 8.0 mm 1 Case/Tray Reference IFU 01-50-4202 for sterilization parameters of the Cannulated Screw instrument cases and contents. 21 6.5/ 8.0 mm Cannulated Screw System Indications & Contraindications INDICATIONS Large Cannulated Screws (5 mm and larger in diameter) are intended for use in: 1. Fixation of fractures in long bones and long bone fragments. 2. Long bone osteotomies (femur, tibia, foot, ankle, olecranon). 3. Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures. Large Cannulated Screws (6.5 mm and larger in diameter) are intended for use in: 1. Slipped capital femoral epiphysis 2. Pediatric femoral neck fractures 3. Tibial plateau fractures 4. SI joint disruptions 5. Intercondylar femur fractures 6. Subtalar arthrodesis 7. Fixation of pelvis and iliosacral joint. CONTRAINDICATIONS 1. Infections. 2. Patient conditions including blood supply limitations, insufficient quantity or quality of bone. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 4. Foreign body sensitivity where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device. 22 References 1. Data on file at Biomet. Test# DVA-107504-DVER. Mechanical testing not necessarily indicative of clinical performance. This material is intended for health care professionals and the Biomet sales force only. Distribution to any other recipient is prohibited. All content herein is protected by copyright, trademarks and other intellectual property rights owned by or licensed to Biomet Inc. or its affiliates unless otherwise indicated. This material must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Biomet. Check for country product clearances and reference product specific instructions for use. For complete product information, including indications, contraindications, warnings, precautions, and potential adverse effects, see the package insert and Biomet’s website. This technique was prepared in conjunction with a licensed health care professional. Biomet does not practice medicine and does not recommend any particular orthopedic implant or surgical technique for use on a specific patient. The surgeon is responsible for determining the appropriate device(s) and technique(s) for each individual patient. Not for distribution in France. Legal Manufacturer Biomet Trauma 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA ©2014 Biomet Trauma • Form No. BMET1050.0 • REV1014 www.biomet.com Authorised Representative Biomet UK Ltd. Waterton Industrial Estate Bridgend, South Wales CF31 3XA UK 0086
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