Catalog Number QD11 |
Device Problem
Component Falling (1105)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported from (b)(6) that the inner metal part fell out of the attachment device.The event was not reported to have occurred during surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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.
|
|
Manufacturer Narrative
|
The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.It was determined that the bushing came loose from the housing.The assignable root cause was determined to be due to worn out components from normal use and servicing over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|