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

Model Number	SWIVELOCK, SP BC KL 4.75MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
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 10/06/2025, a sales representative reported via email that the suture eyelet of an ar-2324kbcsp biocomposite knotless swivelock anchor broke while attempting to insert the anchor into the lateral row.The procedure was completed successfully, and no fragments were retained in the patient.This occurred during a rotator cuff repair procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 10/08/2025: all broken pieces were retrieved from the patient.The case was completed with a replacement ar-2324kbcsp biocomposite knotless swivelock anchor.The incident did not result in any surgical delay, additional anesthesia, or reported adverse effects.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-2324kbcsp, batch 15434458, was received for investigation.The eyelet of the device was damaged.Functional testing was not performed due to the damage present on the device.The most likely cause of the failure can be attributed to misuse, such as misaligned insertion or prying/leveraging the device during insertion.The complaint allegation is confirmed.Refer to the attached investigation photos.

• Brand Name: SWIVELOCK, SP BC KL 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: 23303883
• Report Number: 1220246-2025-04626
• Device Sequence Number: 14668486
• Product Code: MAI
• UDI-Device Identifier: 00888867384538
• UDI-Public: (01)00888867384538(11)250512(17)290430(10)15434458
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/16/2025

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 KL 4.75MM
• Device Catalogue Number: AR-2324KBCSP
• Device Lot Number: 15434458
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown