ADJUSTABLE SOLUTIONS FOR FRACTURES AT RISK. Tibia Technique Guide

Transcription

1 ADJUSTABLE SOLUTIONS FOR FRACTURES AT RISK Tibia Technique Guide

2 Contributing Surgeons Roy W. Sanders, M.D. Chairman, USF Dept. of Orthopaedics President, Florida Orthopaedic Institute Chief of Orthopaedics, Tampa General Hospital Editor-in-Chief, Journal of Orthopaedic Trauma Tampa, FL J. Tracy Watson, M.D. Professor, Orthopaedic Surgery Chief, Orthopaedic Traumatology Dept. of Orthopaedic Surgery Saint Louis University School of Medicine St. Louis, MO The PRECICE UNYTE TM system is indicated for open and closed fracture fixation, pseudoarthrosis, or malunions and nonunions of long bones. This technique guide offers guidance but, as with any such technique guides, each surgeon must consider the particular needs of each patient and make appropriate clinical decisions, as required. All non-sterile devices must be cleaned and sterilized before use. Multi-component instrument assemblies must be disassembled prior to cleaning. Please refer to the corresponding Important Safety Information. It is the surgeon s responsibility to discuss all relevant risks with the patient prior to surgery.

3 CONTENTS Introduction 2 Technical Details 3 PRECICE UNYTE TM Tibia Technique Guide 4 Patient Positioning 4 Entry Point 5 Fracture Reduction 6 Implant Selection 6 Intramedullary Reaming 7 Guide Arm Assembly and Device Insertion 7 Proximal Screw Targeting and Screw Selection 8 Screw Driver Assembly and Proximal Screw Insertion 9 Manual Compression 10 Distal Screw Targeting and Screw Selection 10 Distal Screw Insertion 11 End Cap Insertion (Optional) 11 Magnet Location Marking 12 Intraoperative External Remote Controller (ERC) Compression 13 Final Closure 14 Postoperative ERC Compression or Distraction 14 Implant Removal 15 PRECICE UNYTE Tibia System 16 Important Safety Information 19

4 INTRODUCTION PRECICE UNYTE TIBIA SYSTEM NuVasive Specialized Orthopedics ȚM a division of NuVasive, an innovative company focused on developing implantable technology to treat a broad spectrum of spinal and orthopedic applications, has developed a novel intramedullary device for tibia fractures at risk. The PRECICE UNYTE Tibia System is the latest advancement in osteoplasty surgery utilizing compression osteosynthesis and distraction osteogenesis. This state-of-the-art magnetically controlled internal fixation device utilizes a remote control to non-invasively compress and distract the tibia in the consolidation of open or closed fractures, malunion and nonunions. SYSTEM COMPONENTS The PRECICE UNYTE Tibia system comprises the following components: Magnetically Controlled Intramedullary Tibia Device Proximal and Distal Fully Threaded Screws End Caps (optional) Instrument Tray External Remote Controller EXTERNAL REMOTE CONTROLLER (ERC) 2

5 TECHNICAL DETAILS PRECICE UNYTE TIBIA SYSTEM mm 14mm 28mm 42mm Geometry 51mm Proximal Diameter Shaft Diameter 12.5mm 11.5mm Distal Diameter 8.5mm Overall Lengths 240 to 375mm (15mm increments) Proximal Bend 10 Herzog Distal Bend mm Fixation 240 to 375mm lengths Proximal Screws Proximal Pattern 5.0mm fully threaded screws 14mm 45 28mm 45 (opposing) 42mm M/L Distal Screws 4.5mm fully threaded screws Distal Pattern 6mm M/L 15mm A/P 24mm M/L Performance Initial Compression 10mm 8.5mm Initial Distraction Total Stroke 20mm 30mm 31mm 4 6mm Lateral 15mm A/P 24mm Lateral Tibia Device Diameter 11.5mm Fully Threaded Screws End Caps Sizes Sizes 240 to 375mm (in 15mm increments) 5.0mm fully threaded screws Length = 20 to 75mm 0mm 5mm 10mm 15mm 20mm 4.5mm fully threaded screws Length = 20 to 75mm 3

6 TIBIA TECHNIQUE GUIDE 1 PATIENT POSITIONING Place the patient supine on a radiolucent table and position the knee for a tibial intramedullary device procedure. Position a small bump under the ipsilateral sacroiliac joint. A triangle may also be helpful for patient positioning and device insertion (Fig. 1). Fluoroscopic visualization of the entire tibia is essential and should be confirmed prior to prepping and draping the patient s entire limb from the iliac crest to the foot/ankle. Locate the joint line using a wire or similar technique. Use a surgical marking pen to mark the site. 90 to 110 (Fig. 1) 4

7 TIBIA TECHNIQUE GUIDE 2 ENTRY POINT Flex the knee to assist in finding the proximal entry point. Under biplanar fluoroscopic guidance, find the entry point into the proximal tibia, just anterior to the joint line to be in line with the tibial shaft. A more distal entry point may result in damage to the posterior cortex during device insertion (Fig. 2). The center point of the portal is located slightly medial to the lateral tibial spine, as visualized on the A/P radiograph, and immediately adjacent and anterior to the anterior articular margin, as visualized on the true lateral radiograph. The A/P starting position can be adjusted for planned angular deformity or to target the distal tibial segment. Make a small vertical incision around the pin and spread the soft tissues using hemostats. After confirming correct pin placement on A/P and lateral radiograph views (Fig. 2), position the Soft Tissue Protector and insert the Honeycomb within the portal. If pin placement is suboptimal, then rotate the Honeycomb within the Soft Tissue Protector to the desired location and insert another Steinmann pin (Fig. 3). Once you have reached the optimal placement, ream over the Steinmann pin with a rigid 12.5mm Entry Reamer (Fig. 4). Protect the patellar tendon with retractors. (Fig. 2) (Fig. 3) (Fig. 4) 5

8 TIBIA TECHNIQUE GUIDE 3 FRACTURE REDUCTION Assemble the Non-ratcheting T-handle to the Fracture Reducer. Using the Guide Wire Chuck, insert a Ball Tip Guide Wire through the Fracture Reducer and into the medullary canal (Fig. 5). Under proper fluoroscopy, align the Fracture Reducer with the tibial shaft to help reduce fracture. Remove the Fracture Reducer and leave the Guide Wire in the canal. 4 IMPLANT SELECTION (Fig. 5) After the fracture is reduced, the Nail Measuring Gauge may be used to select the appropriate length. Insert the Nail Measuring Gauge over the Guide Wire. The radiopaque marker in the distal end of the Nail Measuring Gauge represents where the proximal end of the PRECICE UNYTE TM Tibia Device will be. The proximal end of the Nail Measuring Gauge will denote the calibrations for the most applicable length of the PRECICE UNYTE Tibia Device when the proximal end of the Guide Wire is positioned against the slot in the Nail Measuring Gauge (Fig. 6). 6 (Fig. 6)

9 TIBIA TECHNIQUE GUIDE 5 INTRAMEDULLARY REAMING Attach a Hudson quick connect to the reamer prior to reaming the canal with flexible reamers, beginning with 7mm and increasing by 0.5mm increments until the tibial canal is over-reamed by 1.0 to 1.5mm greater than the planned diameter of the PRECICE UNYTE Tibia Device. A Guide Wire Pusher may be used to secure the Guide Wire when removing the flexible reamers from the canal (Fig. 7). (Fig. 7) 6 GUIDE ARM ASSEMBLY AND DEVICE INSERTION After determining the appropriate PRECICE UNYTE Tibia Device length, assemble the Targeting Arm by threading the Jig Locking Bolt into the proximal threads of the PRECICE UNYTE Tibia Device until fully engaged. Once the PRECICE UNYTE Tibia Device is attached, assemble the Targeting Guide Jig to the Targeting Arm for proximal screw targeting of the device (Figs. 8, 9). Tip On the back table, insert the Drill Sleeve into the Guide Tube and through the Targeting Guide Jig. Verify correct alignment of the 4.3 x 355mm Drill Bit through the Drill Sleeve and PRECICE UNYTE Tibia Device. Confirm all three proximal screw holes in this manner. When the Targeting Arm and Targeting Guide Jig are correctly assembled to the PRECICE UNYTE Tibia Device, position the targeting assembly in the A/P position and advance the device through the tibial canal (Fig. 10). (Fig. 8) (Fig. 9) (Fig. 10) 7

10 TIBIA TECHNIQUE GUIDE 7 PROXIMAL SCREW TARGETING AND SCREW SELECTION Place the Guide Tube through the first proximal screw hole of the Targeting Guide Jig. Through the Targeting Guide Jig, position the Trocar through the Guide Tube and make a small stab incision. Advance the Trocar through the soft tissue until the tip is seated against the cortex (Fig. 11). Verify with the image intensifier that the Guide Tube is positioned on the tibial cortex. Remove the Trocar and position the Drill Sleeve through the Guide Tube. Use the 4.3 x 355mm Drill Bit to penetrate both cortices. Confirm correct placement under image intensification. After drilling both cortices, select the appropriate 5.0mm screw length by reading off the calibration on the 4.3 x 355mm Drill Bit using the Screw Depth Gauge as shown (Fig. 12). The fully threaded 5.0mm screws are available in 5mm increments from 20 to 75mm lengths. *The Screw Depth Gauge may also be used to read the calibration by sliding it down the Guide Tube. (Fig. 11) (Fig. 12) 8

11 TIBIA TECHNIQUE GUIDE 8 SCREW DRIVER ASSEMBLY AND PROXIMAL SCREW INSERTION Insert the Screw Capture Rod through the 3.5mm Hex Cannulated Screwdriver. Hand-tighten the Screw Capture Rod to the appropriate length 5.0mm screw. Assemble the 3.5mm Hex Cannulated Screwdriver with the Screw Capture Rod and attach it to the Ratcheting Straight Handle (Figs ). Remove the Drill Sleeve and position the screw into the Guide Tube to direct it through the PRECICE UNYTE Tibia Device. Hand-tighten the screw into the near cortex (Fig. 17). Remove the Ratcheting Straight Handle and untighten the Screw Capture Rod to release the screw. Use the 3.5mm Hex Solid Screwdriver, attached to the Ratcheting Straight Handle, to achieve final secure fixation and to fully seat the screw. Repeat this sequence for the second and third proximal screws (Fig. 18). (Fig. 13) (Fig. 14) (Fig. 15) (Fig. 16) (Fig. 17) (Fig. 18) 9

12 TIBIA TECHNIQUE GUIDE 9 MANUAL COMPRESSION Following proximal screw insertion, manually correct any residual distraction at the fracture site. Note Confirm through fluoroscopy that the device has been compressed sufficiently to achieve bony contact at the fracture site. If manual compression outside device is required, take care to avoid high impact on device. 10 DISTAL SCREW TARGETING AND SCREW SELECTION The freehand technique is used to position screws in the A/P and M/L distal holes of the PRECICE UNYTE TM Tibia Device. Depending upon which screw is to be inserted, align the C-arm in either the A/P or lateral position to view perfect overlapping circles. For the perfect overlapping circle technique, first find the drill hole using the finger hole of an instrument. Make a small skin incision and use the appropriate diameter drill to create a pilot hole through both cortices (Figs. 19, 20). Select the length for the first distal screw by sliding the Direct Measuring Sleeve over the 3.9mm Drill Bit and reading the measurement identified while the distal tip of the Drill Bit is positioned right at the far cortex (Fig. 21). *The Distal Screw Depth Gauge can also be used to determine appropriate screw length. Note Find the drill hole by first using the finger hole of an instrument. Confirm positioning with image intensifier. (Fig. 20) (Fig. 21) (Fig. 19) 10

13 TIBIA TECHNIQUE GUIDE 11 DISTAL SCREW INSERTION Tighten the screw by hand (Fig. 22). Release the Screw Capture Rod and perform final tightening of the screw with the 3.5mm Hex Solid Screwdriver. Repeat the steps for additional distal screws. (Fig. 22) 12 END CAP INSERTION (OPTIONAL) Based on surgeon preference, an End Cap may be used to help prevent bony ingrowth into the proximal thread of the device. Multiple End Caps are available for all device sizes and are cannulated for ease of insertion. Attach the non-ratcheting T-handle to the 3.5mm Hex Cannulated Screwdriver. Turn the Non-ratcheting T-handle clockwise until the End Cap fully sits inside the proximal portion of the device. Take care not to cross thread the End Cap into the PRECICE UNYTE Tibia Device. (Fig. 23) 11

14 TIBIA TECHNIQUE GUIDE 13 MAGNET LOCATION MARKING Evaluate the final implant construct under image intensification. Locate the magnet within the PRECICE UNYTE TM Tibia Device (Fig. 24). Be sure the C-arm is perpendicular to the implant to visualize the correct position of the central magnet. Use a surgical skin marker to put a transverse line on the patient s skin directly over the location of the center of the PRECICE UNYTE magnet. Provide a surgical marker postoperatively to the patient to refresh the line as it fades. CENTER OF MAGNET PRECICE UNYTE IMPLANT REFERENCE IMAGE (Fig. 24) 12

15 TIBIA TECHNIQUE GUIDE 14 INTRAOPERATIVE EXTERNAL REMOTE CONTROLLER (ERC) COMPRESSION If compression is desired, place the ERC in a sterile bag and place it directly over the transverse mark on the skin. Make sure you have properly aligned the ERC on the patient s tibia and the magnets are pointed toward the patient s feet (Figs. 25, 26). Use the implant locator window on the ERC to properly position it over the mark on the patient s skin. Referencing the ERC Manual, activate the ERC to compress the fracture site until sufficient bony contact is achieved and confirmed under fluoroscopy. It takes seven minutes to achieve 1.0mm of compression. Confirm under image intensification that the compression has occurred by comparing the pre-compressed image to the post-compressed image. Note Not all fractures are the same. Avoid over-compression of the fracture site by reviewing under fluoroscopy. (Fig. 25) (Fig. 26) 13

16 TIBIA TECHNIQUE GUIDE 15 FINAL CLOSURE After the 1.0 to 2.0mm compression of the PRECICE UNYTE TM Tibia Device, the surgical incisions are irrigated and closed in standard fashion. Sterile dressings are applied and the lower leg is placed in a CAM boot for postoperative comfort and proper foot/ankle positioning and alignment. Make certain that the skin mark noting the location of the magnet within the PRECICE UNYTE Tibia Device is prominent and visible. This will facilitate proper positioning of the ERC to postoperatively compress, if additional compression is needed, or if distraction is needed, to aid in either fracture union or restore the proper length of a limb length discrepancy. 16 POSTOPERATIVE ERC COMPRESSION OR DISTRACTION After the desired intraoperative compression is achieved, the surgical incisions are irrigated and closed in standard fashion. Make certain that the skin mark noting the location of the magnet within the PRECICE UNYTE Tibia Device is prominent and visible. This will facilitate proper positioning of the ERC to postoperatively compress if additional compression is needed, or if distraction is needed to restore the proper length of a limb length discrepancy. At the patient s first postoperative visit, new fluoroscopy images should be taken and assessed to measure any residual gap that may have occurred. Using the ERC, begin to actively compress until gap is eliminated. If cortical contact is achieved, it is recommended to compress only as needed to maintain continual compression. Additional follow-up may be needed to maintain continual compression until bone healing is achieved. 14

17 TIBIA TECHNIQUE GUIDE 17 IMPLANT REMOVAL The PRECICE UNYTE Tibia Device is recommended to be removed, provided radiological evidence of full bone consolidation is present. Each surgeon must determine the appropriate time for removal, based upon clinical evaluation of the patient. Using the image intensifier, locate the proximal and distal screws. Make small incisions, as required, and remove all but one of the screws using the 3.5mm Hex Solid Screwdriver and Non-ratcheting T-handle. Then, remove the End Cap and thread the Tapered Extractor to the PRECICE UNYTE Tibia Device. Attach the Removal Rod to the Tapered Extractor, remove the final screw and proceed with device removal (Fig. 27). The Slotted Mallet may be used to assist in device removal, as needed. Perform skin closure with routine techniques. (Fig. 27) 15

18 TIBIA SYSTEM PRECICE UNYTE TM GENERAL INSTRUMENT TRAY MODEL # DESCRIPTION MODEL # DESCRIPTION 1 FXR1-000 Fracture Reducer 9 2 HDL2-000 Non-ratcheting T-handle 10 3 RMB1-000 Slotted Mallet 11 4 GWP2-000 Guide Wire Pusher 12 5 SDG1-000 Screw Depth Gauge 13 6 NMG1-000 Nail Measuring Gauge 14 7 SDS mm Hex Cannulated Screwdriver, Short 15 7 CRS1-000 Screw Capture Rod, Short 16 8 RVR1-000 Removal Rod 17 8 CTA1-000 Tapered Extractor 18 XRR1-000 ERM TBA1-000 LKL1-000 HDL1-000 DMS1-000 GWC1-000 STS1-000 HCB1-000 SDS1-001 Intraoperative X-ray Ruler 12.5mm Entry Reamer Tommy Bar Locking Hex Key, Long Ratcheting Straight Handle Direct Measuring Sleeve, Short Guide Wire Chuck Soft Tissue Protector Sleeve Honeycomb 3.5mm Hex Solid Screwdriver, Short

19 TIBIA SYSTEM PRECICE UNYTE TIBIA INSTRUMENT TRAY MODEL # TAT2-000 TAT1-000 LBD1-001 STP1-000 IMP1-000 LBT1-000 IMP2-000 GTT1-000 DST1-000 TCT1-000 DGT1-000 DESCRIPTION Targeting Guide Jig, Tibia Targeting Arm, Tibia Locking Bolt Driver Soft Tissue Protector Paddle Impactor, Short Jig Locking Bolt, Tibia Impactor, Long Guide Tube, Tibia 4.3mm Drill Sleeve, Tibia Trocar, Tibia Screw Depth Gauge

20 TIBIA SYSTEM IMPLANT OFFERINGS MODEL # DESCRIPTION INITIAL COMPRESSION AVAILABLE INITIAL DISTRACTION AVAILABLE TOTAL STROKE AVAILABLE* CDT T240 CD Tibia Nail, 11.5 x 240mm 10mm 20mm 30mm CDT T255 CD Tibia Nail, 11.5 x 255mm 10mm 20mm 30mm CDT T270 CD Tibia Nail, 11.5 x 270mm 10mm 20mm 30mm CDT T285 CD Tibia Nail, 11.5 x 285mm 10mm 20mm 30mm CDT T300 CD Tibia Nail, 11.5 x 300mm 10mm 20mm 30mm CDT T315 CD Tibia Nail, 11.5 x 315mm 10mm 20mm 30mm CDT T330 CD Tibia Nail, 11.5 x 330mm 10mm 20mm 30mm CDT T345 CD Tibia Nail, 11.5 x 345mm 10mm 20mm 30mm CDT T360 CD Tibia Nail, 11.5 x 360mm 10mm 20mm 30mm CDT T375 CD Tibia Nail, 11.5 x 375mm 10mm 20mm 30mm * After full compression is achieved. FULLY THREADED SCREWS 4.5mm SILVER 5.0mm GOLD MODEL # LENGTH MODEL # LENGTH TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm TSA mm DISPOSABLES END CAPS MODEL # DESCRIPTION MODEL # DESCRIPTION WIR2-229 DBT1-4.3 DBS1-4.3 DBS1-3.9 NU S NU-S x 229mm Guide Wire Single Trocar 4.3mm Calibrated Drill 4.3mm Drill Bit, Short 3.9mm Drill Bit, Short 3.0 x 900mm Sterile Ball Nose Guide Wire 3.2 x 330mm Sterile Threaded Pin TEC1-000 TEC1-005 TEC1-010 TEC1-015 TEC1-020 End Cap, 0mm End Cap, 5mm End Cap, 10mm End Cap, 15mm End Cap, 20mm 18

21 IMPORTANT SAFETY INFORMATION PRODUCT DESCRIPTION The PRECICE UNYTE Tibia System is composed of an implantable intramedullary device, screws, reusable instruments, and a hand-held External Remote Controller (ERC). The PRECICE UNYTE Tibia device is a sterile single use device that is surgically implanted using the instruments and screws. The ERC is used daily after implantation to non-invasively lengthen or shorten the implant. During the implantation procedure, the PRECICE UNYTE Tibia device can be adjusted in length to provide an appropriate amount of compression for the proper fracture reduction. Following implantation, the PRECICE UNYTE Tibia device utilizes distraction osteogenesis to compensate for any limb discrepancy. Traditional intramedullary surgical techniques are used to implant and secure the proximal and distal sections of the PRECICE UNYTE Tibia device to the target bone. The Magnetic Actuator of the PRECICE UNYTE Tibia device includes a small internal magnet and gearing. After positioning the External Remote Controller (ERC) against the skin in the vicinity of the internal magnet, activation of the ERC causes the magnet to rotate and either lengthen or shorten the PRECICE UNYTE Tibia device. During the surgical implantation procedure and after the device has been secured to the bone, the device can be shortened up to 10mm to provide compression for fracture reduction. Over a period of days or weeks, sequential distractions can be performed to increase the limb length to compensate for any length discrepancies encountered during the fracture reduction process. The PRECICE UNYTE Tibia device remains implanted for approximately six months after the last distraction to allow bone consolidation to occur. Once the physician determines that the implant has achieved its intended use and is no longer required, the PRECICE UNYTE Tibia device is to be removed using standard surgical techniques. INTENDED USE The PRECICE UNYTE Tibia system is intended for open and closed fracture fixation, pseudoarthrosis, or malunions and nonunions of long bones. CONTRAINDICATIONS Patients with Gustilo open fracture Classification Grade IIIB or IIIC fractures. Patients with pre-existing nerve palsies. Infection or pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the device. Metal allergies and sensitivities. Patients whose distance from the surface of the treated limb to the intramedullary canal is greater than 51mm. Patients with an irregular bone diameter that would prevent insertion of the PRECICE UNYTE Tibia Device. Patients in which the PRECICE UNYTE Tibia Device would cross joint spaces or open epiphyseal growth plates. Patients in which there is an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity. Patients unwilling or incapable of following postoperative care instructions. Patients weighing in excess of 114kg. WARNINGS Patients with an open fracture resulting in a limb length discrepancy may also have soft tissue damage as a result of severe trauma. It is important that soft tissue damage is addressed prior to lengthening to minimize the risk of infection. Limb lengthening also involves soft tissues; it is important to allow the soft tissue to heal prior to the lengthening procedure. The PRECICE UNYTE Tibia device cannot withstand the stresses of full weight bearing. Patient should utilize external support (e.g., crutches) and/or restrict activities until consolidation occurs. Do not use if the sterile packaging has been damaged or is open upon receipt. Metallic implants can loosen, fracture, corrode, migrate, or cause pain. Due to the presence of a magnet, use of the PRECICE UNYTE Tibia System is not recommended in patients with pacemakers. The PRECICE UNYTE Tibia System may not be appropriate for patients with poly-trauma. Use of the PRECICE UNYTE Tibia System in patients with an active infection of the treated bone is not recommended. Smoking, chronic steroid use and the use of other anti-inflammatory drugs have been determined to affect bone healing and could potentially have an adverse effect of the bone regenerate during the lengthening process. The PRECICE UNYTE Tibia device is supplied sterile and is for single use only. The device has not been tested to be cleaned, sterilized for multiple uses, or by a method other than gamma irradiation. If the device is used more than once, the device could cause a serious infection. Assure that patient with implanted PRECICE UNYTE Tibia device does not enter MRI unit. Effect of high magnetic field of MRI unit has not been studied with respect to the implanted magnet, and is therefore unknown. Unsafe in Magnetic Resonance Imaging environments. The PRECICE UNYTE Tibia System has not been evaluated for safety and compatibility in the MR environment. The PRECICE UNYTE Tibia System has not been tested for heating or migration in the MR environment. The PRECICE UNYTE Tibia device should be retracted only by a physician. Retraction should be monitored and confirmed using radiography. 19

22 IMPORTANT SAFETY INFORMATION PRECAUTIONS Do not use this device without proper training in both device implantation and adjustment. Refer to External Remote Controller (ERC) Operator s Manual OM0005 for operation of the External Remote Controller. During the distraction phase, patient should not participate in contact sports or other high risk activities that cause more than 20% of body weight to be loaded on treated limb. These activities may resume upon sufficient bone consolidation, but only as determined by the physician. Examine all PRECICE UNYTE Tibia system components carefully prior to use to assure proper working condition. If you suspect a component to be faulty or damaged, do not use. CAUTIONS The PRECICE UNYTE Tibia system is for prescription use only by the order of a physician. Device should be removed after implantation time of no more than one year. Utilize extreme caution when handling instruments made from magnetic materials such as stainless steel in proximity of the magnet of the PRECICE UNYTE Tibia Device, as materials will be attracted to each other. Do not bend the PRECICE UNYTE Tibia Device or otherwise modify or damage the implant. Follow the ERC Operator s Manual (OM0005) to assure proper alignment between the ERC and magnet of the PRECICE UNYTE Tibia Device. The implantable device is only to be used by a trained licensed physician. Please refer to the PRECICE UNYTE Tibia system instructions for use for complete Important Safety Information. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. EXTERNAL REMOTE CONTROLLER The implantable device is only to be used by a trained licensed physician. Weekly X-ray imaging to assess actual distraction length is recommended. Only use the ERC in a manner consistent with the Operator s Manual; any alternative use may result in injury or damage to the device. The ERC may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the ERC or shielding the location. Persons with a pacemaker or a similar medical aid should not handle or be exposed to the ERC. The strong magnetic fields may affect the operation of such devices. The ERC uses strong permanent magnets. Misuse of this device can cause serious personal injury. Make sure the work area is free of metal objects before use. This includes personal items such as jewelry, watches, keys, and cellular phones. Always return the ERC to its protective case when not in use. Only operate the device by holding onto both of the handles provided. The ERC may be pulled away from your hands if brought too close to other magnetic objects. Always maintain a firm grip on the ERC and be very aware of other objects in your work area. If the device is damaged, beware that magnet shards from broken magnets are very sharp. Always handle broken magnets with thick protective gloves. Never place the ERC near electronic media or appliances. Do not open the unit; severe personal injury or damage to the device may result. Only use the supplied power cord or an equivalent hospital grade cord rated for 10 Amps minimum. Do not use this device in the presence of flammable anesthetics. If retraction of the implant is needed, never retract the implant more than the amount lengthened over the previous day. Failure to follow this warning may result in pulling biological material that may have adhered to the rod of the implant into the internal space of the actuator of the implant. The ERC should only be placed immediately over the area of the patient s body at the magnetic portion of the nail. Do not place the ERC near any other parts of the body, for example, portions of the body which may contain ferromagnetic material-containing implants. When the ERC is not being actively used on the patient, it should always be kept within its protective case. This device has not been tested for compatibility in Magnetic Resonance Imaging (MRI) environments and should not enter an MRI unit. Please refer to the PRECICE UNYTE Tibia System instructions for use for complete Important Safety Information. Caution: US Federal law restricts this device to sale by or on the order of a physician. 20

23 NOTES

24 For more information about this product, please contact your local sales representative. 101 Enterprise, Suite 100 Aliso Viejo, CA Phone: Fax: NuVasive, Inc. All rights reserved. and NuVasive are registered trademarks of NuVasive, Inc. in the United States, and may be registered in other countries. PRECICE is a registered trademark of NuVasive Specialized Orthopedics, Inc. in the United States, and may be registered in other countries. PRECICE UNYTE is a trademark of NuVasive Specialized Orthopedics, Inc. NuVasive Specialized Orthopedics is a trademark of NuVasive, Inc. Rx Only. The PRECICE UNYTE Tibia System is composed of an implantable intramedullary nail, screws, reusable instruments, and a hand-held External Remote Controller (ERC). The PRECICE UNYTE nail is a sterile single use device that is surgically implanted using the instruments and screws. The ERC is used daily after implantation to non-invasively lengthen or shorten the implant. The PRECICE UNYTE Intramedullary Nail System is intended for open and closed fracture fixation, pseudoarthrosis, or malunions and nonunions of long bones. Contraindications include patients with Gustilo open fracture classification grade IIIB and IIIC fractures, infection or pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the device, metal allergies and sensitivities, patients whose distance from the surface of the treated limb to the intramedullary canal is greater than 51mm, patients with an irregular bone diameter that would prevent insertion of the nail, patients in which the nail would cross joint spaces or open epiphyseal growth plates, patients in which there is an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease or evidence of inadequate vascularity, patients unwilling or incapable of following postoperative care instructions, patients weighing in excess of 114kg. The implantable device is only to be used by a trained licensed physician. Please refer to the PRECICE UNYTE Tibia System instructions for use for complete Important Safety Information. Caution: US Federal law restricts this device to sale by or on the order of a physician. 17-NUVA-0623