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.The actual device was returned for evaluation.Quality engineering evaluated the impactor device and the reported condition that the device is cracked and bent beyond use was confirmed.An assessment was performed, and it was found that the device failed visual inspection.During the assessment of the device, it was observed that the device was broken at the t-handle in two pieces, consistent with having been dropped or other radial (off-axis) force.The cause for the found defect can be linked to improper handling.The assignable root cause was determined to be traced to the user, which is user error.
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It was reported that during an unspecified surgical procedure it was observed that the cup inserter of the impactor device was cracked and bent beyond use.During in-house engineering evaluation it was determined that the device was broken in two pieces at the t-handle.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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