(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/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent 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 motor power was too low, reverse locking mechanism was stuck and the switch was sluggish.It was further noted that the device failed pre-test for general condition, marking and labeling, reverse locking mechanism, function of soft mode switch (safety system), triggers for forward/reverse mode, power with test bench and starting behavior.It was noted in the service order that the button was stuck.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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