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.D10: concomitant med products and therapy dates: cutter device, (b)(6) 2024.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 having a locking issue was not confirmed.Therefore, an assignable root cause was not determined.However, the device producing heat, 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 china that during service and evaluation, it was determined that the motor device produced heat and made an excessive noise.It was further determined that the device failed pretest for noise assessment and handpiece temperature assessment.It was noted in the service order that after an unknown surgery, it was observed that the device had a lock issue.The device could not detach the consumable device.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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