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	03/12/2025
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 3/13/2025, it was reported by a sales representative via email that an ar-2324kbcsp 4.75 mm biocomposite knotless swivelock suture became loose after being hit with a mallet during insertion, additionally, the eyelet of the swivelock broke.This was discovered during a procedure on (b)(6) 2025.Additional information requested on 3/31/2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed per picture attached that showed the eyelet had broken off.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The method of bone preparation was not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• 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: 21753727
• Report Number: 1220246-2025-01178
• Device Sequence Number: 15890006
• Product Code: MAI
• UDI-Device Identifier: 00888867384538
• UDI-Public: (01)00888867384538(11)240919(17)280831(10)15319966
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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
• Device Model Number: SWIVELOCK, SP BC KL 4.75MM
• Device Catalogue Number: AR-2324KBCSP
• Device Lot Number: 15319966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown