Examination of the returned lps inserter extractor confirmed damage to the threads.The root cause is being attributed user/error/technique.The damage on the threads indicate the threads were not fully seated into the mating stem before impacting.A complaint database search on the provided product code found similar events which were attributed to misuse and or product wear out.Based on the root cause determination of user/error/technique, the need for corrective action is not indicated.Monitor complaints through (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.
|