The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device was making excessive noise.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi ¿ (b)(4).
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It was reported from (b)(6) that during service and evaluation, it was determined that the sagittal saw with key device was making excessive noise, the thread of the saw blade coupling was damaged, and the housing was worn.It was further determined that the device failed pretest for check the saw blade coupling, and general condition.It was noted in the service order ¿article defect¿.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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