(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 improper handling, which is user error/misuse/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 observed that the compact air drive device had housing damage.It was noted that the motor was blocked, had seized, and was rough running.It was also noted that the device failed pre-repair diagnostic tests for air leak, function of soft mode switch, function of the triggers for forward/reverse mode, untrue running, excessive noise, the power with test bench, and starting behavior.It was noted in the service order that the device had a problem with the actuation of the triggers.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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