(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.It was further determined that the motor was running rough.The assignable root cause was determined to be due to premature wear from normal use and servicing.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 small battery drive device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that the motor seized, jammed, was moving heavy and defective.It was further determined that the device failed for check the off/osc/on switch mode function, check the oscillation angle and for check switching function.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any 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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