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 of the device not working was not confirmed.Therefore, an assignable root cause was not determined.However, the device having vibration, identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
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It was reported by singapore that during service and evaluation, it was determined that the motor device had vibration.It was further observed that the device had component damage.It was further determined that the device failed pretest for visual assessment, loctite assessment and cable assessment.It was noted in the service order that the device did not work at all.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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