MAUDE Adverse Event Report: ARTHREX, INC. 2.4MM KNOTLESS SUTURETAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	2.4MM KNOTLESS SUTURETAK
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
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 30-dec-2025, a sales representative reported via email that an ar-2424phs peek knotless hip suturetak suture anchor pulled out of bone.The surgeon subsequently redrilled and attempted to insert another ar-2424phs peek knotless hip suturetak suture anchor, which broke in half during insertion.The procedure was completed using two knotless fibertak anchors and one cinchlock device.This was discovered during a hip arthroscopy/pincer procedure on (b)(6) 2025.Additional information was requested on 02-jan-2026.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was received on 12-jan-2026: on insertion, both ar-2424phs peek knotless hip suturetak suture anchor implants fractured.The implants were removed, and all detached fragments were retrieved from the patient.The procedure was completed using two ar-3636h self-punching 1.8 knotless hip fibertak soft anchors and one non-arthrex implant.The event resulted in an estimated 5¿10-minute delay to redrill and pass suture for the final anchor, with additional anesthesia administered during this time.No adverse patient effects were reported.

• Brand Name: 2.4MM KNOTLESS SUTURETAK
• 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: 24078488
• Report Number: 1220246-2026-00215
• Device Sequence Number: 9895773
• Product Code: GAT
• UDI-Device Identifier: 00888867443624
• UDI-Public: (01)00888867443624(11)231211(17)281130(10)15178334
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232340
• 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,Followup,Followup
• Report Date (Section B): 05/06/2026

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: 2.4MM KNOTLESS SUTURETAK
• Device Catalogue Number: AR-2424PHS
• Device Lot Number: 15178334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 05/04/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 01/21/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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