SYNTHES OBERDORF 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
Partial Blockage (1065); Mechanical Jam (2983)
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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, jammed, moving heavy and running rough.It was further determined that the device could no longer be loaded and was running with difficulty.Therefore, the reported condition was confirmed.The assignable device root cause was determined to be due to wear/strain from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was discovered that the gear was blocked, seized and running rough on the oscillating saw attachment device.It was further determined that the device was running with difficulty.It was noted in the service order that the device could no longer be loaded.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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