SMITH & NEPHEW, INC. PATELLA RESECTION GUIDE; PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL
|
Back to Search Results |
|
Model Number 71440391 |
Device Problems
Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 08/31/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that during inspection, patella resection guide was noticed to have a screw missing.
|
|
Manufacturer Narrative
|
The device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the screw is missing from the patella resection guide.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|