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

Model Number	SWIVELOCK, SP PEEK 5.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2025
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 (b)(6) 2025, it was reported by a sales representative via email that an ar-2323psp self-punching peek swivelock tip broke with light malleting taps.The case was completed using two additional ar-2323psp self-punching peek swivelocks.All broken fragments were removed, and the procedure was completed successfully.This issue was discovered during an rcr procedure on (b)(6) 2025.Additional information was received on 19-dec-2025: the anchor was removed from the patient, and the repair was completed using additional ar-2323psp self-punching peek swivelock anchors.The case was delayed by approximately 8¿10 minutes, resulting in an estimated 8¿10 minutes of additional anesthesia time.
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 a use error, including improper bone preparation and/or excessive mechanical or tensile forces, misalignment, and/or prying or levering the device during insertion or use.Dfu-0362-eo revision 4 self-punching pushlock® and swivelock® suture anchors.G.Precautions 4.Swivelock only: during anchor insertion, ensure that the angle of the anchor insertion is coaxial to that of the previously prepared bone socket.7.Swivelock only: do not use excessive force when inserting the eyelet into bone to avoid device damage.If device is not advancing after repeated malleting, a pilot hole should be created.If the eyelet becomes unusable after repeated malleting, discard it and use a new implant.8.Ensure that the angle of anchor insertion is perpendicular to the bone.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: SWIVELOCK, SP PEEK 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: 23961056
• Report Number: 1220246-2026-00068
• Device Sequence Number: 9528566
• Product Code: MAI
• UDI-Device Identifier: 00888867384491
• UDI-Public: (01)00888867384491(11)250611(17)300531(10)15450332
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K222263
• 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): 04/20/2026

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 PEEK 5.5MM
• Device Catalogue Number: AR-2323PSP
• Device Lot Number: 15450332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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