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: the actual device was returned for evaluation.Quality engineering evaluated the impactor device and the reported condition that the device was no longer firing was confirmed.The device was visually and functionally assessed and determined to operate with low power, and the anvil automatically extended when manually retracted due to trap internal pressure.The anvil was manually retracted and held in the retracted position for a few seconds, the pressure was released allowing the impactor to operate as intended.It was further determined that the device failed pretest for impactor operation assessment.The assignable root cause of these conditions was determined to be related to improper handling and premature wear.Udi - (b)(4).
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It was reported that during testing it was observed that the impactor device was no longer firing.During in-house engineering evaluation it was determined that the anvil automatically extended when manually retracted due to trap internal pressure.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 become available, a supplemental medwatch will be submitted accordingly.
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