MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II TKA FEM TRIAL LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Model Number 74031225

Device Problem Nonstandard Device (1420)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2020

Event Type  malfunction  

Event Description

It was reported that during a training lab at the office, it was noted that there is a burr in the sliding track of the trial.The box cut guide will not properly slide into place because of this burr.Also, the device exhibits signs of wear and tear.No surgery or patient were involved.

Manufacturer Narrative

The device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the rails are cracked on the jrny ii tka fem trial lt sz 5.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 mode.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.

• Brand Name: JRNY II TKA FEM TRIAL LT SZ 5
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10437488
• MDR Text Key: 203863190
• Report Number: 1020279-2020-04132
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010671967
• UDI-Public: 03596010671967
• Combination Product (y/n): N
• PMA/PMN Number: K121443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74031225
• Device Catalogue Number: 74031225
• Device Lot Number: 16MBG0020
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1