It was reported by china that during service and evaluation, it was determined that the device ran in locked position.It was determined that the device had a cord and component damage.It was further determined that the device failed pretest for visual assessment, safety assessment and air pump assessment.It was noted in the service order that during an unspecified surgical procedure, it was discovered that the device did not function.It was further reported that the device started working and then it stopped.It was not reported if there were any delays in the surgical procedure.It was reported that a spare device was used to complete the surgery.There was patient involvement reported.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 report 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.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 stopping by itself and not functioning was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device running in locked position, identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).
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