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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 november 21, 2025, a sales representative reported via phone that the tip of an ar-2324bcsp 4.75 mm biocomposite swivelock® anchor broke during a rotator cuff repair procedure on (b)(6) 2025.The failure occurred while impacting the anchor, and the fragment was retrieved.The patient had average bone quality, and the site was not prepped using an instrument prior to insertion.The event caused an approximate two-minute delay, requiring additional anesthesia.The procedure was completed using an ar-2324bcc biocomposite swivelock® suture anchor.No patient harm was reported.
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 user error, including improper bone preparation and/or improper surgical technique associated with the device.Directions for use dfu-0362-eo revision 4 self-punching pushlock® and swivelock® suture anchors.E.Warnings: 5.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.Pushlock only: insert the driver until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during final advancement of the anchor body.5.Pushlock only: ensure that the anchor body is in full contact with the bone before advancing the anchor body.6.Insertion in very hard bone may require pre-punching a bone socket to avoid damage to the 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 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: 23759185
• Report Number: 1220246-2025-05523
• Device Sequence Number: 10131149
• Product Code: MAI
• UDI-Device Identifier: 00888867384514
• UDI-Public: (01)00888867384514(11)250630(17)290531(10)15458671
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K222263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 15458671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown