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, it was determined that the reported condition that the device displayed an e2(handpiece lock engaged) error code was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device had unintended activation/motion.The assignable root cause was determined to be due to component failure from wear.(b)(4).
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It was reported by china that during service and evaluation, it was determined that the motor device had unintended activation/motion and pin pushed back in the connector.It was further determined that the device failed pretest for safety assessment.It was noted in the service order that during an unspecified surgical procedure, it was discovered that the device displayed an e2(handpiece lock engaged) error code.It was not reported if there were any delays to the surgical procedure.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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