Examination of the returned instrument confirmed the complaint.The root cause appears to be attributed to misuse; the drill bit may have been pulled out instead of turning to remove as intended.A complaint database search finds no other reported incidents against the provided product and lot combination.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|