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

Model Number	SWIVELOCK, SP BC KL 5.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/09/2025, a distributor reported via email that an ar-2323kbcsp knotless biocomposite swivelock sp had the peek eyelet snapped off during a competitive trial.The broken piece was retrieved from the patient, and the case was completed.This was discovered during a subscap repair procedure on (b)(6) 2025.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an ar-2323kbcsp, with batch number 15179943, revealed that the eyelet was damaged.Therefore, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse due to prying/leveraging the device during use.

• Brand Name: SWIVELOCK, SP BC KL 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: 21980084
• Report Number: 1220246-2025-01944
• Device Sequence Number: 8879995
• Product Code: MAI
• UDI-Device Identifier: 00888867384453
• UDI-Public: (01)00888867384453(11)231213(17)271130(10)15179943
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K222263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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 5.5MM
• Device Catalogue Number: AR-2323KBCSP
• Device Lot Number: 15179943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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