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

Model Number	SWIVELOCK, SP PEEK KL 4.75MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/11/2025
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-2324kpsp peek knotless swivelock fell apart when attempting to insert the anchor to repair the subscap.A pilot hole was punched, and the eyelet still fell apart and broke after trying to insert the anchor.This was discovered during a procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 05/08/2025: during a rotator cuff repair on (b)(6) 2025, the issue occurred on the back table rather than inside the patient.The anchor was removed, and nothing broke inside the patient.To complete the case, a different ar-2324kpsp implant was used, with no delay and no additional anesthesia administered.No instrument was used to prepare the bone socket, and the patient's bone quality was assessed as poor.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an ar-2324kpsp, with batch number 15289809, revealed that the eyelet was damaged.Therefore, arthrex was able to conclude a most likely cause.The most likely cause can be attributed misuse due to misaligned insertion; or prying/leveraging the device during insertion.

• Brand Name: SWIVELOCK, SP PEEK 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: 21995092
• Report Number: 1220246-2025-01966
• Device Sequence Number: 8312850
• Product Code: MAI
• UDI-Device Identifier: 00888867384552
• UDI-Public: (01)00888867384552(11)240718(17)290630(10)15289809
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/26/2025

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 PEEK KL 4.75MM
• Device Catalogue Number: AR-2324KPSP
• Device Lot Number: 15289809
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: Not provided; 09/19/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/02/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown