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
Output below Specifications (3004)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the bearing was worn out and the device lacked power.Therefore, 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 will be submitted accordingly.
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the oscillating saw attachment device power was low during cutting.There was a thirty minute delay to the planned surgical procedure.It was unknown if a spare device was available for use; however, it was reported that the original device was used to complete the surgical procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.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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