MAUDE Adverse Event Report: ARTHREX, INC. SWIVELOCK, SP BC 5.5MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SWIVELOCK, SP BC 5.5MM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-jan-2026, it was reported by an arthrex subsidiary employee via email that an ar-2323bcsp biocomposite self-punching swivelock anchor experienced a tip peek eyelet split vertically when hammered in without drilling a pilot hole.The procedure was completed using another ar-2323bcsp biocomposite self-punching swivelock without issue.This event occurred during a rotator cuff repair procedure on (b)(6) 2026.No significant surgical delay was reported.No broken fragments remained in the patient.No additional anesthesia was administered, and no adverse patient effects were reported during or following the procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SWIVELOCK, SP BC 5.5MM
• 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: 24163511
• Report Number: 1220246-2026-00297
• Device Sequence Number: 9268736
• Product Code: MAI
• UDI-Device Identifier: 00888867384439
• UDI-Public: (01)00888867384439(11)250226(17)290131(10)15396040
• 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): 05/26/2026

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 5.5MM
• Device Catalogue Number: AR-2323BCSP
• Device Lot Number: 15396040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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