It was reported that during testing the impactor device no longer worked.During in-house engineering evaluation, it was observed that the device operated with low power and the anvil automatically extended when manually retracted due to trapped internal pressure.It was further determined that the device failed pretest for impactor operation assessment.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition that the device had unintended activation/motion, identified during service and repair, was confirmed.The assignable root cause was determined to be due to component failure from wear.Udi: (b)(4).
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