(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 from australia that the motor device was gritty, noisy, broken and did not work properly.During service and evaluation, it was observed that the locking components were damaged and the coupling tool was defective on the device.It was further determined that the device failed safety assessment at pretest.It was unknown if the event occurred during surgery.It was unknown if there was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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