MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS ART ISRT TRL SZ 3-4 11MM LT; PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLY/METAL/POLY

Model Number	74035243
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that on a journey ii bcs art insert trial size 3-4 11mm left, the plastic was shredding and breaking off.This occurred after tka procedure.Procedure finished with the same device.No harm or injury reported on patient.There was no surgical delay.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.A relationship between the device and the reported incident was not corroborated.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II BCS ART ISRT TRL SZ 3-4 11MM LT
• Common Device Name: PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10886542
• Report Number: 1020279-2020-06663
• Device Sequence Number: 16895713
• Product Code: JWH
• UDI-Device Identifier: 00885556156988
• UDI-Public: 00885556156988
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 74035243
• Device Catalogue Number: 74035243
• Device Lot Number: 16KAP9752
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1