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
Device Stops Intermittently (1599); Naturally Worn (2988)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: (b)(4).The actual device was returned without an alleged deficiency.During routine service and repair of the device, it was observed that the device was running intermittently, the coupling head was worn, and the triggers were sticky.Therefore, the reported condition was confirmed.It was also noted that the trigger components were worn, there was corrosion on the internal components, the magnet on the electric motor drive gear came loose and was missing, and the contacts on the electronic control unit (ecu) were corroded.The assignable root cause was determined to be due to wear from normal use and servicing over time.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 that during service and repair/pre-testing, it was observed that the small battery drive device was running intermittently, the coupling head was worn, and the triggers were sticky.The event was not related to surgery.There was no 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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Search Alerts/Recalls
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