MAUDE Adverse Event Report: ARTHREX, INC. CR PLUS TIB BEARING, VIT E, SZ 7, 14MM; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	CR PLUS TIB BEARING, VIT E, SZ 7, 14MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.
Event or Problem Description
On 10/11/2022, it was reported by a sales representative via phone that an ar-523-a714 cr plus tib bearing implant had an issue.During a total knee arthroplasty procedure on 10/6/2022, when the surgeon was trying to use the device, the device failed to engage in the tibial tray, it would not lock, and the peripheral locking mechanism would not engage.The surgeon removed the complaint device from the patient, it was removed in one piece and no piece of the instrument broke inside the patient.Upon investigation, it was stated that the peripheral poly was bent/deformed.The surgeon used another ar-523-a714, lot number unknown to complete the case successfully with no impact to the patient.The complaint device was discarded by the facility.It was stated that this might have happened as an out-of-box event, but it could not be verified as no pictures were taken.

• Brand Name: CR PLUS TIB BEARING, VIT E, SZ 7, 14MM
• Common Device Name: KNEE PROSTHESIS PAT/FEM/TIB
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19567431
• Report Number: 1220246-2024-06112
• Device Sequence Number: 6112748
• Product Code: MBH
• UDI-Device Identifier: 00888867231849
• UDI-Public: 00888867231849
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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 Expiration Date: 06/30/2025
• Device Model Number: CR PLUS TIB BEARING, VIT E, SZ 7, 14MM
• Device Catalogue Number: AR-523-A714
• Device Lot Number: 579202441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown