Additional narrative: (b)(4).Conclusion and justification status for mdr: examination of the returned device found evidence consistent with unsuccessful attempts to assemble the tibial insert to the tray.A device history record review was conducted and no anomalies were found.Although no root cause was conclusively determined, suspected user technique is a possible contributing factor to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action is not indicated.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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