The device, used in treatment, was returned for evaluation.A visual inspection of the returned r3 offset impactor confirms the threads are damaged causing the stated failure.The device shows signs of significant wear/use.A medical investigation was conducted and confirms this case reports that after the lever was pushed to set implant, the r3 impactor made a "clicking sound" and was impossible to tighten.Per complaint details, there was no patient injury, and the procedure was completed with a change of surgical technique and a delay of less than 30 minutes.Since no patient harm is alleged, no further clinical assessment is warranted.A review of complaint history did not reveal additional 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 the risk management file revealed this failure mode was previously identified.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.We consider this investigation closed.
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