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 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).The manufacturing location was unknown.Device manufacture date is currently unavailable.This 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 duplicated and confirmed.The assignable root cause was determined to be due to normal wear from use and servicing over time.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 from (b)(6) that during service and evaluation, it was observed that the eccentric bearings were worn out, seized and were running warm on the oscillating saw attachment device.The device passed all the pre-tests.It was reported in the service order that the device was returned for an unspecified malfunction.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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