This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Device availability - the device is reportedly available for evaluation; however, it has not been received by zimmer biomet uk to date.In the event that the device is received and evaluated, a follow-up report will be sent to the fda to provide results.There are warnings in the package insert that these types of events may occur.Under precautions, number 5 states, "intraoperative fracture or breaking of instruments has been reported.Surgical instruments are subject to wear with normal usage.Instruments, which have experienced extensive use or excessive force, are susceptible to fracture.Surgical instruments should only be used for their intended purpose.Biomet recommends that all instruments be regularly inspected for wear and disfigurement." return expected, not yet received.
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