If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: examination of the returned instrument found the instrument did not function as intended.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.Instrument was reported for an unknown reason.Follow ups were made and no additional information was received.A functional check with a mating drill bit found the instruments holding feature to not depress enough to allow the drill bit to be positioned into drill.The root cause is attributed to wear out.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.Complaints will be monitored under post market surveillance procedures.
|