DEPUY SYNTHES POWER TOOLS SAGITT SAW-ATTACHM F/TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
|
Back to Search Results |
|
Catalog Number 05.001.223 |
Device Problems
Device Inoperable (1663); Defective Device (2588); Temperature Problem (3022)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(b)(6).The 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 confirmed.The assignable root cause was determined to be due to device wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
|
Event Description
|
It was reported by (b)(6) that during service and evaluation, it was observed that the bearing on the saw sagittal attachment device was defective.It was further determined that the needle bearing was defective.It was further determined that the device failed pre-test for free movement, oscillation frequency and saw performance.It was noted in the service order that the device was functionless and heated.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.
|
|
Search Alerts/Recalls
|
|
|