DEPUY SYNTHES POWER TOOLS OSCILLATING SAW ATTACHMENT; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problems
Naturally Worn (2988); Temperature Problem (3022)
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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 bearing eccentric was worn out.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal 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 by (b)(6) that during service and evaluation, it was observed that the bearing and eccentric on the oscillating saw attachment device were worn out.It was noted in the service order that the device was hot when idle.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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