DEPUY SYNTHES POWER TOOLS CAD II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Occlusion Within Device (1423); Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/30/2016 |
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.The assignable root cause was determined to be due to device wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was observed that the pen drive device trigger was blocked and jammed.It was also noted that the device failed pre-test for reverse locking mechanism and fwd/rev mode.It was noted in the service order that the reverse did not work.This event did not occur during surgery.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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