(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 duplicated and confirmed.The assignable root cause was determined to be due to normal wear from use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported in the service order from (b)(6) that the small battery drive device would not work in reverse mode.During service and evaluation, it was observed that the device control unit was not functioning, controller was faulty, engine, tool coupling and controller switch were worn.It was further determined that the device failed the following pre-tests: check the attachment coupling, check the offiosc/on switch mode function and check power with test bench.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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