It was reported by germany that during service and evaluation, it was determined that the reciprocating microsaw attachment device produced heat.It was further observed that the drive shaft was bent.It was further determined that the device failed pretest for visual assessment and temperature assessment.It was noted in the service order that during pre-surgery, it was discovered that the device did not work.It was reported that there were no delays in the surgical procedure.It was not reported if a spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in january 2024.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.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 producing heat, identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from normal wear.(b)(4).
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