DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.010_DL |
Device Problems
Mechanical Problem (1384); Sticking (1597); Vibration (1674); Failure to Advance (2524); Naturally Worn (2988)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device coupling head malfunctioned and would not accept the gauge, the upper trigger was sticking, the electric motor was rotating roughly, the device had strong vibrations and the trigger components and coupling head were worn.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear from normal 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, it was observed that the small battery drive device would not load the attachment device.During service and repair, it was observed that the device coupling head malfunctioned and would not accept the gauge, the upper trigger was sticking, the electric motor was rotating roughly, the device had strong vibrations and the trigger components and coupling head 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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