MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS ART ISRT TRL SZ 5-6 9MM RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74035251
Medical Device Problem Codes	Material Fragmentation (1261); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery, a jrny ii bcs art isrt trl sz 5-6 9mm rt was worn out.In addition, it had chips and scarring from use.This happened before use in patient.Surgery was performed, without any delay.However, it is unknown how the procedure was finished.Patient was not harmed as consequence of this problem.No other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device is extremely worn rendering it inoperable.The device has deep gouges and scratches in the plastic.The device shows signs of extensive use.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 review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.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.

• Brand Name: JRNY II BCS ART ISRT TRL SZ 5-6 9MM RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12291739
• Report Number: 1020279-2021-06213
• Device Sequence Number: 3901035
• Product Code: JWH
• UDI-Device Identifier: 00885556157633
• UDI-Public: 00885556157633
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74035251
• Device Catalogue Number: 74035251
• Device Lot Number: 13BAP9768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1