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1 Biomet Trauma 56 East Bell Drive P.O. Box 587 Warsaw, Indiana USA Revision A Date: Biomet Unite3D Bridge with OsseoTi Technology ATTENTION OPERATING SURGEON DESCRIPTION Biomet manufactures a variety of internal fixation devices intended to aid in the alignment and stabilization of fractures, fusions or osteotomies to the skeletal system of the foot until healing has occurred. These devices are non-bioabsorbable. Biomet manufactures surgical instruments for placement of these devices and does not recommend the use of other manufacturers instruments to insert Biomet implants. MATERIALS Implant: Instruments: Titanium Alloy Stainless Steel Copolyester Titanium Alloy INDICATIONS Biomet Unite3D Bridge implants are intended to be used for: Fracture and osteotomy fixation and joint arthrodesis of the foot. Foot bone fragment and osteotomy fixation and joint arthrodesis Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude bridge placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum CONTRAINDICATIONS 1. Infection 2. Comminuted bone surface that would militate against bridge placement. 3. Patient conditions including blood supply limitations, obesity, and insufficient quantity or quality of bone. 4. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 5. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device. WARNINGS Internal fixation devices aid the surgeon in the alignment and stabilization of skeletal fractures, fusions and osteotomies and provide a means of fracture management in reconstructive surgical applications. While these devices are generally

2 successful in attaining these goals, they cannot be expected to replace normal healthy bone, particularly in the presence of non-union, delayed union, or incomplete healing. The size and shape of bones and soft tissue place limitations on the size and strength of implants. Therefore, it is important that immobilization (use of external support, braces, etc.) of the fracture site be maintained until firm bony union (confirmed by clinical and radiographic examination) is established. Surgical implants are subject to repeated stresses in use, which can result in fatigue fracture. Factors such as the patient s weight, activity level, and adherence to weight bearing or load bearing instructions have an effect on the service life of the implant. The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but also must be aware of the mechanical and metallurgical aspects of the surgical implants. The surgeon is to be thoroughly familiar with the implants, surgical technique and instruments prior to performing surgery. 1. Correct selection of the implant is extremely important. The potential for success in fracture fixation is increased by the selection of the proper type of implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size and strength of implants. Internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal healthy bone. These devices are not designed to withstand the unsupported stress of full weight bearing, or load bearing. 2. The devices can break when subjected to increased loading associated with non-union or delayed union. If healing is delayed, or does not occur, the implant can be expected to break, bend, or fail. Loads produced by weight bearing and activity levels may dictate the longevity of the implant. 3. Implant materials are subject to corrosion. Implanting metals and alloys subjects them to constant changing environments of salts, acids, and alkalis that can cause corrosion. Putting dissimilar metals and alloys in contact with each other can accelerate the corrosion process that may enhance the fracture of implants. Every effort should be made to use compatible metals and alloys when mating components. 4. Correct handling of implants is extremely important. Do not modify implants. Notches or scratches put in the implant during the course of surgery may contribute to breakage. 5. Implants can loosen, fracture, corrode, migrate, or cause pain. 6. The surgical technique should be followed. Deviations from the surgical technique could result in early loosening/failure of the device, or other adverse events as outlined in the following section. Clinical outcome may be affected by component positioning. Proper placement of the implant should take into consideration individual patient anatomy as well as surgeon preference. The surgical technique sets forth guidelines for placement of the device. 7. The patient is to be instructed in the use of external supports and braces that are intended to immobilize the fracture site and limit weight bearing or load bearing. Excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight, and obesity have been implicated with premature failure of certain implants by loosening, fracture, dislocation, subluxation and/or wear. Loosening of the implants can result in increased production of wear particles, as well as accelerate damage to bone making successful revision surgery more difficult. 8. In advance of surgery, the patient is to be made aware and warned of general surgical risks, possible adverse effects, and to follow the instructions of the treating physician. In advance of surgery, the patient is to be advised of the need for regular postoperative follow-up examination as long as the device remains implanted. 9. Patient smoking may result in delayed healing, non-healing and/or compromised stability in or around the placement site. Patient selection factors to be considered include: 1) need for alignment and stabilization of bone fractures, 2) ability and willingness of the patient to follow postoperative care instructions until healing is complete, 3) a good nutritional state of the patient, and 4) full patient skeletal maturity. Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant. Do not treat patients with implants that have been, even momentarily, placed in a different patient. Device and instruments are single use only. After use, the device and instruments may be a potential biohazard. Reuse of devices or instruments labeled for single-use may result in product contamination, patient infection and/or failure of the device or instrument to perform as intended.

3 PRECAUTIONS 1. The patient s ability and willingness to follow instruction is one of the most important aspects of successful fracture management. Patients with senility, mental illness, alcoholism, or drug abuse may be at higher risk of device failure. These patients may ignore instructions and activity restrictions. 2. Specialized instruments are designed for Biomet implants to aid in the accurate implantation of the prosthetic components. The use of instruments or implant components from any other systems can result in inaccurate fit, incorrect sizing, excessive wear and device failure. 3. Intraoperative fracture or breaking of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments that have experienced extensive use or excessive force are susceptible to fracture. Surgical instruments should only be used for their intended purpose. The Unite3D Bridge instruments are intended for single use and should not be reused. 4. All trial, packaging, and instrument components must be removed prior to closing the surgical site. Do not implant. POSSIBLE ADVERSE EFFECTS 1. Nonunion or delayed union which may lead to breakage of the implant. 2. Bending or fracture of the implant. 3. Loosening or migration of the implant. 4. Material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. 5. Particulate wear debris and discoloration from metallic components of implants may be present in adjacent tissue or fluid. It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant. 6. Limb shortening due to compression of the fracture or bone resorption. 7. Decrease in bone density due to stress shielding. 8. Pain, discomfort, or abnormal sensation due to the presence of the device. 9. Infection. 10. Nerve damage due to surgical trauma. 11. Necrosis of bone. 12. Intraoperative or postoperative bone fracture and/or postoperative pain. 13. Inadequate healing. 14. Inadequate range of motion due to improper selection or positioning of components. 15. Unwanted soft tissue damage and/or articular surface damage due to improper bridge placement. 16. Improper reduction, rotation or extension of the bones. 17. Early or late postoperative infection and/or allergic reaction. Biomet Unite3D Bridge with OsseoTi Technology in the Magnetic Resonance Imaging (MRI) Environment Biomet Unite3D Bridge is composed of non-ferromagnetic materials such as Titanium (Ti-6Al-4V). Biomet has performed bench testing and numerical simulations on Fixation Bridge components in a Magnetic Resonance Imaging (MRI) environment. These tests determined the non-clinical effects of MRI based on their scientifically relevant characteristics. MR Safety Information Biomet Unite3D Bridge is determined to be MR Conditional in accordance to ASTM F Standard Practice for Marking Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Conditional refers to an item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. It can be scanned safely under the following conditions: Safety information for the use of MRI procedures (i.e. imaging, angiography, functional imaging, spectroscopy, etc.)

4 pertains to shielded MRI systems under the following specifications: - Static magnetic field of 1.5-Tesla (1.5T) and 3.0-Tesla (3.0T) - Spatial gradient field of 3000-Gauss/cm or less - Maximum MR System reported, whole-body-averaged specific absorption rate (SAR) of up to 4-W/kg for up to 15 minutes of scanning. - Normal or first level controlled mode of the MR system, - The effects of local RF transmit coils have not been tested and are not recommended in the area of the implant - Recommended Good Clinical Practices o The use of porous insulation between the patient and the edge of the bore o Prevention of patient s legs from touching each other and arms/hands from touching body o The presence of other implants or the health state of the patient may require reduction in the above limits. MR Information In non-clinical testing and electromagnetic computer simulations, the Unite3D Bridge produced maximum in-vitro temperature rise as follows: 1.5T MR Systems - Less than 2.2 C when scaled to whole-body-averaged SAR of 2 W/kg for 15-minutes of RF power application. 3.0T MR Systems - Less than 2.2 C when scaled to whole-body-averaged SAR of 2 W/kg for 15-minutes of RF power application. Image Artifacts MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Due to the low magnetic susceptibility of the Ti alloy (about 180 x 10-6 in SI units), image artifact will be modest, likely less than 1 cm beyond the implant. Therefore, it may be necessary to optimize MR imaging parameters for the presence of these implants. Other: Testing of materials used in the Unite3D Bridge indicated no known risks of magnetically induced displacement force or torque for the field conditions given above. Painful stimulation from the pulsed gradients may occur. In this event the scan should be terminated. Selecting pulse sequences with lower gradient intensity should reduce the potential for painful stimulation. HOW SUPPLIED Implants and instruments are individually packaged or packaged in a kit and supplied STERILE. STERILITY Implants are provided sterile by exposure to a minimum dose of 25 kgy of gamma radiation. Do not use any component from an opened or damaged package. Do not resterilize. Single use only. Do not reuse. Do not use implants after expiration date. Instruments are provided sterile by exposure to a minimum dose of 25 kgy of gamma radiation. Do not use any component from an opened or damaged package. Do not resterilize. Single use only. Do not reuse. Do not use instruments after expiration date. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Comments regarding the use of this device can be directed to Attn: Regulatory Affairs, Biomet, Inc., P.O. Box 587, Warsaw, IN USA, Fax: All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated.

5 Symbol Legend Manufacturer Date of manufacture Do not reuse Do not resterilize Caution, see instructions for use Sterilized using ethylene oxide Sterilized using irradiation Sterile Sterilized using aseptic processing techniques Sterilized using steam or dry heat Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Do not use if package is damaged (Pack Damaged) MR Conditional Use by date WEEE device Catalogue number Batch code

6 Flammable Authorized representative in the European Community

7 Biomet Trauma 56 East Bell Drive P.O. Box 587 Warsaw, IN USA Tel: Fax: Biomet UK Limited Waterton Industrial Estate Bridgend CF31 3XA United Kingdom Tel: Fax: IFU Revision A Date: