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.During repair, an evaluation was performed and it was determined that the battery reciprocator device had a sticky trigger, the motor was worn, was making excessive noise, had fluid ingress, would not run, and foreign substance/debris/cleaning/sterilization.It was further determined that the device failed pretest for check for sticky trigger, check the function of the device, and check oscillation frequency with frequency meter.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is improper maintenance.Udi - (b)(4).
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It was reported that the battery reciprocator device had an undetermined malfunction.During in-house engineering evaluation it was determined that the device had a sticky trigger.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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