(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.It was also noted that the bearing eccentric was worn out and the device was blocked.The assignable root cause was determined to be due to device wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
It was reported by (b)(6) that during service and evaluation, it was observed that the power drive coupling on the tool side was broken and torn off and the cover sleeve was loose.It was reported the device failed check for cannulation, untrue running, reverse locking mechanism, function of handpiece, function test, immediate stop, triggers, electronic control unit (ecu) and power with test bench failure.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 this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|