DEPUY SYNTHES POWER TOOLS OSCILL-SAW-ATTACHM W/QUICK-COUPL F/COMPA; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the gear was blocked, seized and rough running.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from use and servicing.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 from (b)(6) that during service and evaluation, it was observed that the oscillating saw attachment device gear was blocked, seized and rough running.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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