(b)(4).(b)(6).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 improper maintenance, which is user error, misuse, and / or abuse.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 discovered that the housing was damaged on the attachment device.It was further determined that the locking mechanism was defective and the device was completely worn out.It was further determined during the pre-repair diagnostics assessment that the device failed for visual assessment, thimble lock operation, nose tube assembly, thimble set screw, lock operation, cutter insertion and for vibration.It was noted on the service order that the device had a blocked cutter.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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