(b)(4).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 wear from normal use and servicing over time.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 the air reamer/drill device motor power was too low.During service and evaluation, it was noted that the device motor power was too low, the hand piece had loss of power, and there was general wear and tear of components.It was also noted that the device failed pre-repair diagnostic tests for status of development, general condition, free movement, immediately stopping assessment, excessive noise, air leak, and power with test stand.It was not reported if this event occurred during a surgical procedure.It was reported that there was no delay in a procedure due to the event.It was not reported if a spare device was available for use.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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