Examination of the returned device confirms the reported event of breakage.(b)(4) was held on 25 jan 2016 to evaluate the increased complaints involving the attune tibial trial extactor (product code 254500138).The review team determined that there was no increased patient risk.Based on a previous evaluation ((b)(4)) for a similar failure by depuy material science, the root cause is attributed to overload.Based on the root cause of overload and (b)(4) determination of no additional patient risk, corrective action was not indicated.Continue to monitor via (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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