(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 improper maintenance, 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 from (b)(6) that the compact air drive device had an unspecified malfunction.During service and evaluation, it was observed that the motor on the device seized, jammed, and was heavy moving.It was noted that the motor was blocked as well as the reverse trigger, and the rear part on the push button was deluded.It was also noted that the device failed pre-repair diagnostic tests for reverse locking mechanism, air leak, function of the soft mode switch (safety system), triggers for fwd / rev mode, the power with test bench, and starting behavior.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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