DEPUY SYNTHES POWER TOOLS AIR REAMER/DRILL II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.606 |
Device Problems
Disassembly (1168); Occlusion Within Device (1423); Device Inoperable (1663); Failure to Shut Off (2939)
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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).(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 improper maintenance, which is user error/misuse/abuse.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 air reamer/drill device ran by itself.It was further determined that the device could not be dismantled, valve tappet was blocked and was lacking maintenance (oil).It was further determined that the device failed pre-test for air leak.It was noted in the service order that the device did not work at all.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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