(b)(4).(b)(6).The reporter¿s complete address was not provided.This 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.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 attachment device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that the bearings were damaged and the colorings were out of the locking sleeve.It was further determined that the bearings in the sleeve were defective and the sleeve was worn.It was observed that the tool could not be inserted.It was further determined that the device failed for visual and cutter insertion assessment.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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