SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
|
Back to Search Results |
|
Model Number 74012413 |
Device Problem
Device Reprocessing Problem (1091)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/30/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Event Description
|
It was reported that prior to tka procedure, during set up inspection process, the journey dcf ap femoral cutting blocks, size 3, was found with contamination inside the block, chemicals remaining around middle part of block.Multiple methods of sterilization trialed.There was no case involved.
|
|
Manufacturer Narrative
|
The device, intended for use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.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 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
|
|
|