MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT TRL LT SZ 3-4 9M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74033641
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trial was broken.I was noticed before it was used.The procedure was completed with the same device.No delay reported.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned trail confirms multiple scratches, deep gouges and burrs in the plastic.The device also has some discoloration on the back side.The device exhibits signs of significant wear and use.The device was manufactured in 2015.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.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.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 CR ISRT TRL LT SZ 3-4 9M
• 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: 10167159
• Report Number: 1020279-2020-02496
• Device Sequence Number: 19358333
• Product Code: JWH
• UDI-Device Identifier: 00885556421925
• UDI-Public: 00885556421925
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (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): 09/09/2020

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: 74033641
• Device Catalogue Number: 74033641
• Device Lot Number: 15JAP9498
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1