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

Model Number	74035261
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, journey ii bcs articular insert trial size 5-6 9mm left broke when trialing.Procedure continued with a change in technique and without a delay.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirms the trial has fractured into two pieces.Both pieces were returned with the device.This device shows significant signs of wear/usage.This device was manufactured in 2013.A medical investigation was conducted and confirms this case reports the trial insert broke during trialing.A photo of the broken device confirms that the two pieces were removed from the patient.Per complaint details, the procedure was completed using a change in technique and reports no patient harm or delay.Therefore, no further clinical assessment is warranted.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 a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.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.

• Brand Name: JRNY II BCS ART ISRT TRL SZ 5-6 9MM LT
• 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: 11229778
• Report Number: 1020279-2021-00590
• Device Sequence Number: 3571028
• Product Code: JWH
• UDI-Device Identifier: 00885556157039
• UDI-Public: 00885556157039
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74035261
• Device Catalogue Number: 74035261
• Device Lot Number: 13KAP9539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention