DEPUY SYNTHES POWER TOOLS QUICK COUPLING FOR K-WIRE F/TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESSORIES AND ATTACHMENT
|
Back to Search Results |
|
Catalog Number 05.001.212 |
Device Problems
Mechanical Problem (1384); Device Inoperable (1663); Physical Resistance (2578)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Additional narrative: (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 bearing was not functioning, rough while running.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper cleaning and maintenance.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 was not functioning and rough while running on the quick coupling device.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
|
|
|