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
Sticking (1597); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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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This is report 2 of 2 for the same event.It was reported that during pre-testing, it was discovered that two small battery drive devices were not working and the triggers were sticking when pulling.There were no delays to the surgical procedure as an identical 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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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device was not working and had no power.It was further observed that the electric motor and electronic control unit were damaged and had no power.It was determined that the trigger components were worn.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear from normal use over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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