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 Codes	Break (1069); Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2025
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 10/09/2025, a sales representative reported via email that an ar-2325pslc peek labral swivelock suture anchor and an ar-2326pslc peek swivelock anchor were misshaped and broke upon insertion.No further details were provided.The issue was identified during a procedure on (b)(6) 2025.Additional information has been requested on 10/10/2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.-complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.Per dfu-0087-eo - e.Warnings - 6.Bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.G.Precautions - 3.Make sure to use the recommended drill bit or punch to create the bone socket.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• 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: 23328415
• Report Number: 1220246-2025-04678
• Device Sequence Number: 10612417
• Product Code: MAI
• UDI-Device Identifier: 00888867026971
• UDI-Public: (01)00888867026971(11)220708(17)270630(10)14979629
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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
• Report Date (Section B): 02/02/2026

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: 14979629
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown