MAUDE Adverse Event Report: ARTHREX, INC. Ø7X 20MM PEEK IF SCRW NON-VENTED; NON-DEGRADABLE FIXATN FASTENER

Model Number	Ø7X 20MM PEEK IF SCRW NON-VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/01/2025, it was reported by an arthrex subsidiary employee via (b)(6) that an ar-4020p-07 fastthread¿ peek interference screw with disposable sheath broke.This occured during a case when the surgeon mounted the screw on the screwdriver and when he tried to place it in the patient, it broke.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted the tip of the screw was damaged and broken.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion and/or prying/leveraging the device during insertion.

• Brand Name: Ø7X 20MM PEEK IF SCRW NON-VENTED
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 21861515
• Report Number: 1220246-2025-01543
• Device Sequence Number: 4606710
• Product Code: MAI
• UDI-Device Identifier: 00888867295001
• UDI-Public: (01)00888867295001(11)230316(17)280229(10)15068814
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 09/26/2025

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: Ø7X 20MM PEEK IF SCRW NON-VENTED
• Device Catalogue Number: AR-4020P-07
• Device Lot Number: 15068814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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