Udi: (b)(4).The actual device was returned for evaluation.During repair, it was determined that the reported condition was confirmed.The assignable root cause was traced to component failure.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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It was reported from (b)(6) that during service and evaluation, it was determined that the battery reamer device operated intermittently.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have 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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