DEPUY SYNTHES POWER TOOLS OSCILL-SAW-ATTACHM W/QUICK-COUPL F/COMPA; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
|
Back to Search Results |
|
Catalog Number 511.801 |
Device Problem
Naturally Worn (2988)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter number (b)(4).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 and eccentric were worn out.Therefore, the reported condition was confirmed.It was further determined that the eccentric was broken and the needle bearing was defective.The assignable root cause was determined to be due normal wear from use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Event Description
|
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.This event did not occur during surgery.There was no patient involvement reported.There were no injuries, delays, or medical intervention associated with this event.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.
|
|
Search Alerts/Recalls
|
|
|