MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II TKA FEM SIZING GDE RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74012456
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, the set screw on the femoral sizing guide broke in and it slid while being pinned in place.Surgeon caught it and no harm was done to the patient.A back-up device was available; however, it is unknown if there was a delay.The patient was not harmed.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the set screw is broke causing the sizing guide not to adjust properly.The device was manufactured in 2018.The device shows signs of significant wear/usage.A medical investigation was conducted this case reports the set screw on the a/p sizer was broken and it slid while being pinned in place.Per email communication, the surgeon "caught it" and no harm was done to the patient.There was no patient injury or delay reported, and the procedure was completed using a backup device.Since no patient harm is alleged, no further clinical assessment is warranted.A review of complaint history on the listed part revealed no prior complaint 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.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.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.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.

• Brand Name: JRNY II TKA FEM SIZING GDE 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: 10788650
• Report Number: 1020279-2020-06180
• Device Sequence Number: 2959844
• Product Code: JWH
• UDI-Device Identifier: 03596010672049
• UDI-Public: 03596010672049
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 74012456
• Device Catalogue Number: 74012456
• Device Lot Number: 18LBG0099
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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