Examination of the returned instruments confirmed the reported event of the tips being damaged.The overall condition of the instruments indicates heavy usage.Tightening the internal rod before fully inserting the hex head tip in the holes may widen the slots of the holder, creating an oversized condition and damaging the internal rod.The root cause is attributed to device wear from normal use and servicing.Based on the root cause determination of device wear from normal use and servicing, the need for corrective action is not indicated.Continue to monitor per sep-(b)(4).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.
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