It was reported that the impactor device and undetermined malfunctions.During in-house engineering evaluation it was determined that the device was operating with low power, and the anvil would automatically extend when manually retracted due to trapped 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.The exact date of the event was not reported.All available information has been disclosed.If additional information should become 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: the actual device was returned for evaluation.Quality engineering evaluated the impactor device, and the reported condition was confirmed.The device was visually inspected as received and it was found to pass visual inspection.An assessment was performed, and it was determined that the device operated with low power, and the anvil was automatically extending when manually retracted due to trapped internal pressure.This is considered premature wear of the seals.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.The assignable root cause of these conditions was determined to be due to improper handling and premature wear.(b)(4).
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