MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT TRL LT SZ 3-4 11M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74033643
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that one jrny ii cr isrt trl lt sz 3-4 11m had a chip on it, probably caused by over use.As this was noticed upon cleaning and sterilization activities, there was not patient involvement.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned trail confirms there are scratches, gouges and burrs in the device.The device show signs of significant wear and use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality 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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JRNY II CR ISRT TRL LT SZ 3-4 11M
• 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: 12573819
• Report Number: 1020279-2021-07401
• Device Sequence Number: 11606983
• Product Code: JWH
• UDI-Device Identifier: 00885556421901
• UDI-Public: 00885556421901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: 74033643
• Device Catalogue Number: 74033643
• Device Lot Number: 18CB00577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1