The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this case reports that the screw driver is stripped.Per complaint details, the device was being used outside the patient, and the procedure was completed using a backup device with minimal delay and no patient injury.Therefore, since no patient harm is alleged, no further assessment is warranted at this time.A visual inspection confirmed the threads are damaged on the accord dual ended hex driver, which would cause the device not to function as intended.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.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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