MAUDE Adverse Event Report: Arthrex, Inc. Ø9X 20MM PEEK IF SCRW NON-VENTED; NON-DEGRADABLE FIXATN FASTENER

Model Number	Ø9X 20MM PEEK IF SCRW NON-VENTED
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 02 july 2026, it was reported by a sales representative via email that the patient had surgery on (b)(6) 2025.The procedure was a left knee acl single stage revision with bptb (non-irradiated graft by conmed) and an ar-4020p-09, 9x 20mm peek if scrw non-vented was used.The patient told the surgeon he hears squicky sound when he half squats.The patient underwent a knee scope on (b)(6) 2026, during which it was found that the screw was in the joint, not in the femoral tunnel.The peek screw was removed from the posterior compartment, and medial meniscus repair/surgery was also performed.The case was completed successfully, removing the screw.There was case involvement.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: Ø9X 20MM PEEK IF SCRW NON-VENTED
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50034900
• Report Number: 1220246-2026-04042
• Device Sequence Number: 13217840
• Product Code: MAI
• UDI-Device Identifier: 00888867295025
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: Ø9X 20MM PEEK IF SCRW NON-VENTED
• Device Catalogue Number: AR-4020P-09
• Device Lot Number: 15319746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown