The device, used in treatment, was returned for evaluation.A visual inspection confirmed one of the tips is broke off the outer-grip locking fem implant impactor.The device shows significant signs of wear/usage.A medical investigation was conducted and confirms based on the information provided, the root cause of the reported event could not be definitively concluded, although per the visual product evaluation, ¿significant signs of wear/usage¿ was noted.The patient impact beyond the reported modified surgical procedure could not be determined.However, confirmation of a retrieved foreign body and should the ¿grasping hook¿ fragment be retained, potential corrosion and local irritation/migration could not be ruled out.It was reported that the procedure was successfully completed using a backup s&n instrument.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
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