If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as conclusion and justification status for mdr: examination of the returned device confirms thread damage to the inserter and outer perimeter of the body.A complaint database search on the provided product code identified similar reports which were attributed to inadvertent user error.Based on the investigation, 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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