(b)(4).(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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It was reported by (b)(6) that the battery reamer/drill device had an undetermined malfunction.During service and evaluation, it was observed that the battery reamer/drill device control unit was not functioning and was defective.It was noted that the bearings, seals, and planet carriers were worn.It was also noted that the device failed pre-repair diagnostic tests for function of the off/on/rev mode.It was not reported if this event occurred during a surgical procedure.It was reported that there was no delay in a procedure due to the event.It was not reported if a spare device was available for use.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 report will be submitted accordingly.
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