Device was used for treatment, not diagnosis.(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error/misuse/abuse.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 during service and evaluation, it was determined that the control unit of the battery reamer drill device was not functioning and was defective.It was further determined that the device failed pretest for change 10 times from forward to reverse at full speed, check the off/forward/reverse mode, and trigger test.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 the event was not reported, however, it was reported that the event occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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