(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 strain/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 during service and evaluation, it was observed that the angle attachment device had worn bearings.It was noted that the sleeve and the bearings were worn, the tip of sleeve is damaged and has been running hot, the screw in thimble is loose, and the tool is difficult to clamp.It was further noted that the device failed pre-repair diagnostic tests for thimble lock operation, thimble set screw, and cutter insertion.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.
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