TFN Set Screw Product Information & Technique TFN Set Screw / In-Service / June 2012 / DJ9056B 1 Index – Key Features – Indications – Implants & Instrumentation – Preparing for a Case – Technique – Care & Maintenance TFN Set Screw / In-Service / June 2012 / DJ9056B 2 Key Features TFN Set Screw / In-Service / June 2012 / DJ9056B 3 Key Features Features: – Set Screw configuration allows for intraoperative choice to either lock or allow sliding of the blade or screw – Serrated surface on Set Screw is designed to prevent blade or screw sliding – Set Screw controls blade or screw rotation and limits amount of sliding (when sliding is permitted) – Set Screw is keyed to the nail for ease of assembly – Instruments and Set Screw for use with existing TFN nails, blades and screws – Instruments ensure proper tightening torque for a secure construct TFN Set Screw / In-Service / June 2012 / DJ9056B 4 Indications TFN Set Screw / In-Service / June 2012 / DJ9056B 5 Indications As part of TFN, the Set Screw is indicated for: – Stable and unstable pertrochanteric fractures – Intertrochanteric fractures – Basal neck fractures – And combinations thereof The long TFN is additionally indicated for: – Subtrochanteric fractures – Pertrochanteric fractures associated with shaft fractures – Pathologic fractures of osteoporotic bone (including prophylactic use) in both trochanteric and diaphyseal regions – Long subtrochanteric fractures – Proximal or distal nonunions – Malunions and revisions TFN Set Screw / In-Service / June 2012 / DJ9056B Short Long (170 mm & 235 mm) (300 mm - 460 mm) 6 Implants & Instrumentation TFN Set Screw / In-Service / June 2012 / DJ9056B 7 Featured Implants Implants Set Screws for Titanium Trochanteric Fixation Nail, sterile 04.032.000S 125˚ 04.032.001S 130˚ 04.032.002S 135˚ TFN Set Screw / In-Service / June 2012 / DJ9056B 8 Instrumentation New Instruments for Set Screw Insertion 03.010.477 5.0 mm Hexagonal Screwdriver Shaft, with 6 mm Hexagonal Coupling 03.231.013 6 Nm Torque Limiting Blue T-Handle, with 6 mm Hexagonal coupling Also Available 03.231.018 6 Nm Torque Limiting Blue-Handle, with 6 mm Hexagonal coupling 690.485 Label Sheet for TFN TFN Set Screw / In-Service / June 2012 / DJ9056B 9 Preparing for a Case TFN Set Screw / In-Service / June 2012 / DJ9056B 10 Preparing for a Case: Graphic Case TFN Insertion Set (105.641) TFN Locking Set (105.362 / 105.643) TFN Auxilary Instrument Set (105.646) TFN Set Screw / In-Service / June 2012 / DJ9056B Sterile Implants 11 Technique - This presentation shows the entire technique for insertion of TFN with a TFN Screw. - The optional steps for inserting a Set Screw are included. - The Set Screw may be used with a blade, if desired. TFN Set Screw / In-Service / June 2012 / DJ9056B 12 Technique Preoperative Implant Selection – Use the AO preoperative planner to determine nail length, nail diameter and neck angle – Check magnification on the preoperative planner (0% or 15%). Determine typical magnification at institution and adjust measurements accordingly. – Consider canal diameter, fracture pattern, patient anatomy and postoperative protocol. TFN Set Screw / In-Service / June 2012 / DJ9056B 13 Technique Open proximal femur 1. 2. Position Patient – Lateral decubitus or supine – Abduct upper part of body approximately 10-15˚ to contralateral side (or adduct affected leg by 10-15˚) – Reduce the fracture Determine femoral neck angle – Use a 3.2 mm guide wire in one of the three oblique slots on radiographic ruler – Position ruler and take an AP image – Select the angle TFN Set Screw / In-Service / June 2012 / DJ9056B 14 Technique Open proximal femur (Cont.) 3. 4. Determine nail length (long nails) – Take AP of proximal femur and mark skin at proximal end of the ruler – Move image intensifier to distal end of femur & replace ruler at skin mark – Take AP of distal femur – Read nail length, selecting measurement that places distal end of nail at, or just proximal to, the physeal scar, or chosen insertion depth Determine nail diameter – Take AP at level of isthmus – Measurement is tab that fills canal Note: Ruler is not at level of femur; this effects accuracy of measurement TFN Set Screw / In-Service / June 2012 / DJ9056B 15 Technique Open proximal femur (cont.) 5. Identify nail entry point – Lateral View – In line with medullary canal – AP View – Slightly lateral to tip of greater trochanter, in the curved extension of the medullary cavity – Make incision and dissect to bone – Insert 22.0 mm / 17.0 mm protection sleeve, the 17.0 mm / 3.2 mm wire guide, and the 3.2 mm trocar assembly down to bone. Remove trocar. – Lateral angle of nail is 6˚; therefore, insert guide wire at 6˚ angle lateral to shaft of femur, and intersect the centerline of the canal just distal to lesser trochanter. TFN Set Screw / In-Service / June 2012 / DJ9056B x 16 Technique Open proximal femur (cont.) – Insert guide wire through protection sleeve and wire guide – Confirm guide wire placement in both AP and lateral planes – Insert guide wire to depth of approximately 15 cm. – Remove wire guide TFN Set Screw / In-Service / June 2012 / DJ9056B 17 Technique Open proximal femur (cont.) 6. Open Canal – Drill 17.0 mm drill bit to stop – Note: Do not plunge into fracture site. If going through fracture, remove bone on medial fragment to create path for nail. – Remove drill bit and dispose of guide wire – Cannulated Awl may also be used to open canal or expand opening created by drill bit TFN Set Screw / In-Service / June 2012 / DJ9056B 18 Technique Open proximal femur (cont.) 7. Reaming Guidelines (optional) – Using image intensification, ensure fracture reduction has been maintained. – Insert 2.5 mm reaming rod into medullary canal to desired insertion depth – Ream in 0.5 mm increments; advancing reamer with steady, moderate pressure. Partially retract reamer often to clear debris from canal – Ream to diameter at least 1.0 mm greater than the nail diameter – Remove the reaming assembly, leaving the reaming rod in place – Note: the nail can be passed over the 3.0 mm reaming rod with straight ball tip, if used. – Nail length may be determined using the reaming rod measuring device and a 950 mm reaming rod or guide rod. TFN Set Screw / In-Service / June 2012 / DJ9056B 19 Technique – Set Screw Optional Technique: Assemble Set Screw Important: The TFN Set Screw should only be used for fixation in fractures where sliding is not desired. Tang - Select the set screw that coordinates with the angle of the nail (ex. 130˚ set screw for a 130˚ nail) - Using the 5.0 mm hex screwdriver assembly, remove the two piece locking mechanism from the nail. Etch Figure 1 - Note: The set screw is keyed so it can only be inserted into the nail in one direction. - Starting with the tang positioned toward the nail’s etch (Figure 1), insert the set screw until the yellow color band sits just below the proximal end of the nail (Figure 2). Figure 2 TFN Set Screw / In-Service / June 2012 / DJ9056B 20 Technique Insert Nail 1. Assemble insertion instruments – Orient insertion handle laterally and match the geometry of the handle to the nail. – Note: For long nails, the bow of the nail must align with anterior bow of femur. Also confirm left or right nail accordingly. – Pass cannulated connecting screw through the insertion handle into the nail. Secure using the ball hex screwdriver. – Note: Ensure connecting screw is tight to avoid misalignment when inserting the screw through the aiming arm. Do not attach the aiming arm to the handle until the nail is fully inserted. – Verify locking mechanism for screw is not engaged by passing the 5.0 mm hex screwdriver through the cannulated connecting screw and turning counterclockwise until it stops. TFN Set Screw / In-Service / June 2012 / DJ9056B 21 Technique Insert Nail 2. Insert Nail: Short Nail – Orient insertion handle laterally, taking into consideration the anteversion of the femoral head and neck. – Manually insert nail – Under image intensification, verify fracture reduction and insert nail as far as possible by hand. TFN Set Screw / In-Service / June 2012 / DJ9056B 22 Technique Insert Nail 2. Insert Nail: Long Nail – Orient insertion handle anteriorly until nail reaches insthmus. – As nail is advanced, rotate handle so it is positioned laterally for final seating. – This will allow the bow of the long nails to aid nail passage through the 6˚ laterally angled entry point. – Light hammer blows may be used. When using a hammer, monitor the tip of the nail using image intensification. – Verify that there is no evidence of impingement distally. TFN Set Screw / In-Service / June 2012 / DJ9056B 23 Technique Insert Nail (cont.) Using hammer – Slide driving cap into grooves on the insertion handle and secure in place using the 11 mm ratchet wrench or spanner wrench. – Strike the driving cap with a hammer. – Alternatively, thread the slide hammer and hammer guide onto the driving cap and hammer. – Use light blows to seat the nail. – Remove the driving cap. – Important: Confirm nail is tightly connected to the insertion handle, especially after hammering. – If reaming rod was used, remove it once nail crosses fracture site. TFN Set Screw / In-Service / June 2012 / DJ9056B 24 Technique Proximal Locking 1. Verify nail insertion depth and anteversion – Ensure nail is tightly connected to insertion handle. – Securely attach appropriate aiming arm to the insertion handle. – Nail insertion depth can be confirmed by inserting a 3.2 mm guide wire through the aiming arm. – To ensure correct anteversion of the nail, an additional guide wire can be inserted ventral to the femoral neck and into the femoral head. – Take a lateral image of the proximal femur to verify nail rotation and ensure screw will be aimed toward the center of the femoral head. TFN Set Screw / In-Service / June 2012 / DJ9056B 25 Technique Proximal Locking 2. Insert blade guide sleeve – Thread buttress/compression nut onto blade guide sleeve. – Tip: When assembling buttress/compression nut, locate it approximately in the middle of the threaded portion of the blade guide sleeve for insertion into the aiming arm. – Place yellow guide sleeve, 11.0 mm/ 3.2 mm wire guide and 3.2 mm trocar assembly through the aiming arm and to the skin. – Make an incision to accommodate path of sleeve assembly. – Ensure incision and dissection of fascia are in line with path of blade guide sleeve. – Pass sleeve assembly to bone. The buttress/compression nut will snap into the aiming arm. TFN Set Screw / In-Service / June 2012 / DJ9056B 26 Technique Proximal Locking 2. Insert blade guide sleeve (cont.) – Turn buttress/compression nut counterclockwise to advance the blade guide sleeve to the bone. – The buttress/compression nut is locked into the aiming arm, ensuring that the blade guide sleeve will remain in position on the lateral cortex throughout the remainder of the procedure for screw insertion. – Take AP image to confirm blade guide sleeve is on the lateral cortex. – Reconfirm fracture reduction using image intensification. TFN Set Screw / In-Service / June 2012 / DJ9056B 27 Technique Proximal Locking 3. Insert Guide Wire for Screw: Optional technique: Use Guide Wire Aiming Device – Attach Guide Wire Aiming Device to anterior side of aiming arm (where Miss-A-Nail jig is normally attached). – Note: Offset block can be used to add 10 cm of soft tissue clearance – Position C-arm for AP image. Rotate C-Arm until any two orientation lines are symmetric to the blade guide sleeve. – The midline (line between the two orientation lines) represents the guide wire trajectory. – Note: If the nail must be repositioned, retract blade guide sleeve before making the adjustments. TFN Set Screw / In-Service / June 2012 / DJ9056B 28 Technique Proximal Locking 3. Insert guide wire for screw – Remove 3.2 mm trocar and pass a new 3.2 mm guide wire through the drill sleeve to the bone. – Advance the guide wire under power, into the femoral head, stopping approximately 5 mm from subchondral bone. – The guide wire should be centered in the femoral head and neck in both the AP and lateral planes. The tip of the guide wire is positioned at the intended screw tip position. – Confirm guide wire placement in both planes. – Note: If the nail must be repositioned, retract blade guide sleeve before making the adjustments. TFN Set Screw / In-Service / June 2012 / DJ9056B 29 Technique Proximal Locking 3. Insert Guide Wire for Screw: Optional technique: Use Miss-A-Nail – Attach the Miss-A-Nail jig to the aiming arm either anterior or posterior to the nail. – Set the thumbscrews to desired spread position and tighten with 11 mm ratchet wrench. – Pass the 5.6 mm/3.2 mm drill guide through the Miss-A-Nail jig. – Make stab incision and pass sleeve to bone. – Advance 3.2 mm guide wire into femoral head and monitor with image intensifier. – Repeat to place a second wire. – Wires will converge toward the tip of the screw, in the lateral view, but will not touch the screw. – Remove once screw is inserted. TFN Set Screw / In-Service / June 2012 / DJ9056B 30 Technique Proximal Locking 4. Measure for length of 11.0 mm screw – Read screw length (to the tip of the guide wire) directly from the measuring device. – Note: If compression is desired, use a shorter lag screw to avoid protruding too far out of the lateral cortex. TFN Set Screw / In-Service / June 2012 / DJ9056B 31 Technique Proximal Locking 5. Drill for 11.0 mm screw – Remove wire guide – Open lateral cortex by drilling with 11.0 mm tapered drill bit to the stop. – Note: If guide wire has deflected, it may be removed. If guide wire falls out or comes out when drill bit is removed, it does not need to be replaced. Ensure orientation of insertion handle and aiming arm is not altered. – Pass drill stop over the back end of the 6.0 mm/10.0 mm stepped drill bit and adjust the setting to the measured screw length. – Drill to the stop. TFN Set Screw / In-Service / June 2012 / DJ9056B 32 Technique Proximal Locking 6. Tap/Ream (Optional) – Tap/Reamer may be used to prepare pathway for the TFN Screw. – Important: Only use in dense bone. – Pass through the nail and advance manually by turning clockwise until the end of reamer reaches desired screw placement. – Important: Monitoring insertion via the following methods is recommended: – – Use fluoroscopy – Monitor graduation on the instrument shaft in relation to blade guide sleeve Remove by turning counterclockwise. TFN Set Screw / In-Service / June 2012 / DJ9056B 33 Technique Proximal Locking 7. Assemble 11.0 mm screw – Thread compression nut onto inserter/extractor. – Insert helical blade coupling screw into inserter/extractor. – Align arrows on the tabs of the inserter/extractor with flats on the back end of the screw. – Thread coupling screw into screw and tighten. mark 8. Insert 11.0 mm screw – Pass through the nail and advance by turning clockwise until mark on inserter meets flange surface of blade guide sleeve. – The tip of the screw is now at the tip of the guide wire. TFN Set Screw / In-Service / June 2012 / DJ9056B 34 Technique Proximal Locking 9. Align inserter handle – Align handle so it is in the same plane as the femoral shaft (parallel to the femoral shaft axis when viewed laterally). – Note: The handle may be off axis by as much as 10˚. It may not be off axis counterclockwise, as this will prevent the locking mechanism from fully engaging the screw. – Note: Turn the handle 180˚ to advance the screw 1.75 mm (or 360˚ to advance 3.5 mm) – Note: When aligning the handle always turn clockwise, further engaging the screw in the bone (avoiding any gaps between screw and bone) TFN Set Screw / In-Service / June 2012 / DJ9056B 35 Technique Proximal Locking 10. Engage locking mechanism (If using set screw, proceed to slide 38) – Engage locking mechanism to control screw rotation (screw can still slide). – Turn the 5.0 mm hexagonal screwdriver (or the 5.0 mm hexagonal shaft in conjunction with ratchet wrench) clockwise to the stop. – Note: If the locking mechanism is not advanced, the use of an end cap is not possible TFN Set Screw / In-Service / June 2012 / DJ9056B 36 Technique Proximal Locking (cont.) Optional technique: interfragmentary compression – Advance the compression nut until it abuts the blade guide sleeve. – At this point interfragmentary compression can be obtained by turning either the buttress/compression nut or the compression nut clockwise by hand or with assistance of the 4.5 mm pin wrench. – Remove the coupling screw from the screw inserter. – Remove the blade guide sleeve from the aiming arm by depressing the button on the aiming arm and pulling. TFN Set Screw / In-Service / June 2012 / DJ9056B 37 Technique - Set Screw Optional Technique: Engage Set Screw – After insertion of the head element and satisfactory reduction has been achieved, the set screw can be engaged. – Note: If interfragmentary compression or sliding is desired, skip to the optional technique on the following slides. – Insert screwdriver assembly and turn clockwise. After one click, the optimal torque is reached. – Note: The torque limiting handle ensures that the correct torque is achieved, thus ensuring that sliding is prevented. – Check position with C-arm – Proceed with standard TFN Technique, Distal Locking TFN Set Screw / In-Service / June 2012 / DJ9056B 38 Technique - Set Screw Optional Technique: Interfragmentary Compression – Note: The set screw must be engaged to prevent rotation, but not fully locked. This allows the blade or screw to slide during compression, but prevents rotation. – Insert the set screw until it bottoms out (but do not click the torque limiter). Turn the driver counterclockwise a ¼ turn. – Advance the compression nut until it abuts the blade guide sleeve. At this point, interfragmentary compression can be obtained by turning either the buttress/compression nut (attached to the blade guide sleeve) or the compression nut (attached to the screw inserter/extractor) clockwise by hand or with the assistance of the 4.5 mm pin wrench. – To statically lock the blade or screw, reinsert the screwdriver assembly and turn clockwise. After one click, the optimal torque is reached. – Remove coupling screw from insertion device. – Remove the blade guide sleeve from the aiming arm by depressing the button on the aiming arm and pulling out the blade guide sleeve. TFN Set Screw / In-Service / June 2012 / DJ9056B 39 Technique - Set Screw Optional Technique: Sliding with Set Screw – Important: If sliding with the set screw is permitted, an end cap must be used to prevent the set screw from backing out (preventing the blade or screw from rotating, backing out or migrating). Refer to the “Insert End Cap” section of the standard technique guide. – To allow sliding of the blade or screw, insert the set screw until it bottoms out (but do not click the torque limiter). Turn the driver counterclockwise a ¼ turn. The blade or screw will be able to collapse but the set screw will still prevent rotation. – Proceed with standard TFN Technique, Distal Locking, and Insert End Cap (see standard technique guide). TFN Set Screw / In-Service / June 2012 / DJ9056B 40 Technique Distal Locking – Short Nails (170 mm and 235 mm) 1. Reconfirm reduction 2. Drill and measure for locking bolt/screw – Alternative technique: use locking bolt measuring device TFN Set Screw / In-Service / June 2012 / DJ9056B 41 Technique Distal Locking – Short Nails 3. Insert locking bolt or screw – Insert 4.9 mm or 5.0 mm locking screw using the hexagonal screwdriver. – Remove protection sleeve and aiming arm. – Note the insertion depth of the nail as indicated by the rings on the insertion handle for end cap selection. – Remove connecting screw and insertion handle using the ball hexagonal screwdriver or the cannulated shaft and ratchet wrench. – Note: If using SureLock, the insertion handle should remain attached to the nail. TFN Set Screw / In-Service / June 2012 / DJ9056B 42 Technique Distal Locking – Long Nails (300 mm and 460 mm) 1. Reconfirm reduction – Take AP and Lateral images – For static locking use superior hole – For dynamic locking, use inferior locking hole 2. Align image – Obtain perfect circle in center of screen. – Important: Ensure nail is securely connected to handle. 3. Determine Incision point – Place Scalpel blade or k-wire on the skin over the center of the hole to mark the incision point and make a stab incision. TFN Set Screw / In-Service / June 2012 / DJ9056B 43 Technique Distal Locking – Long Nails (300 mm and 460 mm) 4. Center drill bit in locking hole – Under image intensification, insert the tip of the 4.0 mm three-fluted drill bit for radiolucent drive through the incision and place it onto the bone. – Keep the drill bit oblique to the x-ray beam until the tip is centered in the locking hole. 5. Drill – Tilt the drive until the drill bit is in line with the beam and appears centered in the outer ring. The drill bit will nearly fill the locking hole image. – Hold the drill firmly in this position and drill through both cortices. TFN Set Screw / In-Service / June 2012 / DJ9056B 44 Technique Distal Locking – Long Nails (300 mm and 460 mm) 6. Measure – Read locking bolt/screw length directly from depth gauge 7. Insert locking bolt/screw – Insert 4.9 mm locking bolt or 5.0 mm locking screw using the hexagonal screwdriver, holding sleeve and holding sleeve locking device. TFN Set Screw / In-Service / June 2012 / DJ9056B 45 Technique Insert end cap – Note insertion depth of nail as indicated by the rings on the insertion handle. – Remove the connecting screw and insertion handle using the ball hexagonal screwdriver or the cannulated shaft and ratchet wrench. – Use of an end cap is recommended if bony ingrowth into the proximal end of the nail is of concern. Also for reverse oblique intertrochanteric and high subtrochanteric fractures, the nail should sit slightly proud of the greater trochanter to provide an added point of fixation. If the nail has been over inserted, it should be extended by the use of an end cap. – Slide the end cap over the 3.2 mm guide wire into the top of the nail. – Use the 11.0 mm guide wire to tighten the end cap. – The 5.0 mm flexible hex screwdriver, the 5.0 mm hex screwdriver or the 5.0 mm hex shaft and ratchet wrench may be used to insert the end cap without the use of the guide wire. TFN Set Screw / In-Service / June 2012 / DJ9056B 46 Technique Implant removal 1. Disengage locking mechanism – Remove the end cap – Thread the nail extraction screw into the nail. – Use the 5.0 mm hex screwdriver to disengage the locking mechanism. – Tip: Pass the screwdriver through the extraction screw first, to assist with aligning the screw with the top of the nail. – – Conical Extraction Bolt Important: Do not extract the nail at this point. Optional instruments – Extraction screw guide – Used to help center the extraction screw in the top of the nail. – Conical extraction bolt – used instead of extraction screw. Extraction Screw Guide TFN Set Screw / In-Service / June 2012 / DJ9056B 47 Technique Implant Removal 2. Remove screw and locking bolts / screws – Align the tabs on the inserter/extractor with the flats of the screw. – Insert the coupling screw and thread it into the screw. – Extract the screw by turning counterclockwise. – Remove all locking bolts/screws using the 3.5 mm hex screwdriver. 3. Extract nail – Thread the hammer guide and slide hammer assembly onto the back end of the nail extraction screw. – Hold onto the extraction screw and use light hammer blows to extract the nail. TFN Set Screw / In-Service / June 2012 / DJ9056B 48 Care & Maintenance TFN Set Screw / In-Service / June 2012 / DJ9056B 49 Care & Maintenance Intraoperative and postoperative cleaning of instruments – Clean intraoperatively using cleaning stylet – Clean postoperatively using cleaning stylet and cleaning brush – Ensure grooves in blade guide sleeve are free of debris – Clean only with neutral pH detergents approved for use on anodized aluminum Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://www.synthes.com/sites/NA/MedicalCommunity/cleaning-sterilization/Pages/default.aspx or to the below listed inserts, which will be included in the shipping container: Processing Synthes Reusable Medical Devices, Instruments, InstrumentTrays and Graphic Cases: DJ1305 Processing Non-sterile Synthes Implants: DJ1304 TFN Set Screw / In-Service / June 2012 / DJ9056B 50 Thank You. TFN Set Screw / In-Service / June 2012 / DJ9056B 51