(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 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 during service and evaluation, it was observed that the housing on the compact air drive device was damaged.It was further determined that the housing was defective (position pin), and the sealing and pressure pins were wedged/crushed.It was also noted that the device failed pre-repair diagnostic tests for attachment coupling assessment, attachment coupling with attachments assessment, function of the reverse locking mechanism, air leak, function of soft mode switch (safety system), function of the triggers for fwd / rev mode, excessive noise, 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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