MAUDE Adverse Event Report: ARTHREX, INC. TITANIUM SWIVELOCK, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	TITANIUM SWIVELOCK, 4.75X19.1MM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/17/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-2324slm 4.75 mm x 24.5 mm self punching, vented, suture anchor, swivelock suture that holds the tip of the anchor was cut when using the anchor.This was discovered during use with no patient harm.
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 complaint allegation is confirmed by the attached picture, which shows the sutures have been cut/damaged.No pictures of the eyelet and screw were attached.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.The method of bone preparation and the quality of the bone encountered were not specified.Per dfu-0087-eo - g.Precautions - 4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.The most likely cause for the reported failure can be attributed to user error of the device due to improper surgical technique/bone preparation, misalignment of insertion, and/or excessive force used for prying/leveraging the device during insertion.

• Brand Name: TITANIUM SWIVELOCK, 4.75X19.1MM
• 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: 23743465
• Report Number: 1220246-2025-05473
• Device Sequence Number: 21419931
• Product Code: MAI
• UDI-Device Identifier: 00888867026940
• UDI-Public: (01)00888867026940(11)250611(17)300531(10)15450297
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K151342
• 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): 03/13/2026

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: TITANIUM SWIVELOCK, 4.75X19.1MM
• Device Catalogue Number: AR-2324SLM
• Device Lot Number: 15450297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• 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