(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.
|
It was reported by south africa that the attachment device had an undetermined malfunction.During service and evaluation, it was observed that attachment device had worn components: bearings.It was further determined that the bearing on the tip and the tip were worn, screw was loose and tip vibrated.It was further determined that the device failed pre-repair diagnostic tests for thimble set screw assessment, vibration, and temperature assessment for 'less than or equal to 118° @ tip'.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.
|