SYNTHES OBERDORF CAD II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Break (1069); Defective Component (2292); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(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.However, the assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported by (b)(6) that the compact air drive device jacobs chuck coupling device was broken and the reverse function with the trigger was not working.During service and evaluation, it was noted that the device coupling tool side was defective and there was foreign body material stuck in the coupling shaft.It was further noted that the device failed pre-repair diagnostic tests for function of the attachment coupling, function of the attachment coupling with attachments, function of the triggers for fwd/rev mode, and the power with test bench.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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Search Alerts/Recalls
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