MAUDE Adverse Event Report: ARTHREX, INC. SWIVELOCK, SP BC 4.75MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SWIVELOCK, SP BC 4.75MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
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 26-jan-2026, an arthrex subsidiary employee reported via email that an ar-2324bcsp biocomposite swivelock sp exhibited weak fixation strength and became unusable during use.The procedure was completed using a replacement ar-2324bcsp biocomposite swivelock sp.There was no significant delay; no additional anesthesia was administered.This was discovered during an arthroscopic rotator cuff repair procedure on (b)(6) 2026, with no reported patient harm.Additional information was received on 29-jan-2026: it was reported that the fixation strength of the device appeared weak during use.The implant pulled out immediately after deployment, which indicated the reduced fixation strength.

• Brand Name: SWIVELOCK, SP BC 4.75MM
• 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: 24324587
• Report Number: 1220246-2026-00556
• Device Sequence Number: 15821623
• Product Code: MAI
• UDI-Device Identifier: 00888867384514
• UDI-Public: (01)00888867384514(11)250203(17)290131(10)15382598
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222263
• 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): 05/18/2026

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: SWIVELOCK, SP BC 4.75MM
• Device Catalogue Number: AR-2324BCSP
• Device Lot Number: 15382598
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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