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

Model Number	74012456
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the adjustment knob on sizer is loose from use.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the adjustment knob is loose causing the device not to adjust properly.The device shows signs of significant wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.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.We consider this investigation closed.

• Brand Name: JRNY II TKA FEM SIZING GDE RT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11655874
• Report Number: 1020279-2021-02961
• Device Sequence Number: 3497598
• Product Code: JWH
• UDI-Device Identifier: 03596010672049
• UDI-Public: 03596010672049
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 74012456
• Device Catalogue Number: 74012456
• Device Lot Number: 13CBG0028
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1