MAUDE Adverse Event Report: ARTHREX, INC. Ø8X 20MM PEEK IF SCRW NON-VENTED; NON-DEGRADABLE FIXATN FASTENER

Model Number	Ø8X 20MM PEEK IF SCRW NON-VENTED
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that an ar-4580-24 fiberstitch implant 1.5 was prematurely deployed.Additionally, an ar-4020p-08 fastthread peek interference screw (8 mm × 20 mm) did not engage with the driver, and its threads were compromised.The case was completed using another fiberstitch implant.This occurred during an acl with meniscal repair and let procedure on (b)(6) 2025, with no reported patient harm.Additional information was requested on 23-dec-2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a use error, including improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: Ø8X 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: 24035905
• Report Number: 1220246-2026-00132
• Device Sequence Number: 15717823
• Product Code: MAI
• UDI-Device Identifier: 00888867295018
• UDI-Public: (01)00888867295018(11)230522(17)280430(10)15095499
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: Ø8X 20MM PEEK IF SCRW NON-VENTED
• Device Catalogue Number: AR-4020P-08
• Device Lot Number: 15095499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown