Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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.Visual analysis found nicks at the tip of the attachment end.The flat areas on the attachment end are stripped / worn.The fluted area of the reamer also exhibits nicks with missing material.The root cause is attributed to wear out.For the initial medwatch, a follow-up medwatch will be filed as appropriate.
|