DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.010 |
Device Problems
Break (1069); Sticking (1597); Device Operates Differently Than Expected (2913); Naturally Worn (2988)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/03/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device had no power (did not function), the trigger was sticking, the coupling head was worn, the electric motor was worn and the wire insulation on the electronic control unit was damaged.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear from use and servicing over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during pre-surgery setup, it was observed that the small battery drive device would not do anything.During in-house engineering evaluation, it was observed that the trigger was sticking, the device did not function, the wire insulation on the electronic control unit was damaged, and the coupling head and electric motor were worn.There were no delays to the planned surgical procedure.A spare device was available for use.There was no patient involvement reported.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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Search Alerts/Recalls
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