SMITH & NEPHEW, INC. JOURNEY FEM IMPL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number 74012831 |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/20/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device, used in treatment, was returned for evaluation.A visual inspection of the returned impactor confirms the device fractured into two pieces.Both pieces were returned for evaluation.This device was manufactured in 2019.This device exhibits signs of significant wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.Based on this investigation, the need for corrective action is not indicated.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.
|
|
Event Description
|
It was reported that, during surgery, the device was found broken.A back-up device was used.Surgery was not delayed.Patient was not harmed.
|
|
Search Alerts/Recalls
|
|
|