MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK SWI-VELOCK,3.5X 15.8MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH,PEEK SWI-VELOCK,3.5X 15.8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-2325pslc, suture anchor, peek swivelock®, 3.5 mm x 15.8 mm, vented, its anchor broke during insertion.This was detected during a right deltoid ligament of the ankle surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-2325pslc.There were no patient harm and no secondary procedure needed.
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 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 user error, specifically improper bone preparation, excessive force, and/or incorrect surgical technique.The complaint allegation was not confirmed upon reviewing the customer¿s attached picture.The image shows the ar-2325pslc suture anchor, peek swivelock®, 3.5 mm × 15.8 mm, vented, with an anchor positioned at the inserter shaft tip; however, it is unclear from the picture whether the anchor is broken or damaged.

• Brand Name: SUTR ANCH,PEEK SWI-VELOCK,3.5X 15.8MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 23888133
• Report Number: 1220246-2025-05802
• Device Sequence Number: 21238127
• Product Code: MAI
• UDI-Device Identifier: 00888867026971
• UDI-Public: (01)00888867026971(11)240627(17)290531(10)15279723
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101823
• 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): 04/02/2026

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: SUTR ANCH,PEEK SWI-VELOCK,3.5X 15.8MM
• Device Catalogue Number: AR-2325PSLC
• Device Lot Number: 15279723
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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