SMITH & NEPHEW, INC. GII MIS DCF AP CT BLK 3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number 71441151 |
Device Problem
Naturally Worn (2988)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 08/13/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that the gii mis dcf ap ct blk 3 is worn from excessive use and need to be replaced.There was no case involved.No patient harm or surgical delay was reported.
|
|
Manufacturer Narrative
|
Additional information in d4 (lot number and expiration date), d10 and h4.Results of investigation: the device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned cutting block confirms there are several burrs and gouges in the metal causing the stated failure.This device was manufactured in 2005.This device exhibits signs of significant wear/usage.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.
|
|
Search Alerts/Recalls
|
|
|