Results of investigation: the device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the drill guide handle epoxy coating over the internal witness wire has degraded and has begun to come off.The device shows significant signs of wear/usage.This failure mode has been previously identified.Although we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture; the information available as a result of this investigation indicates that corrective/ preventive action is warranted.This issue has been submitted to our corrective action preventive action process in accordance with applicable internal procedures.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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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