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	04/08/2025
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 04/08/2025, it was reported by a sales representative via phone that an ar-2324kbcsp 4.75 mm biocomposite knotless swivelock anchor, self punching with blue #2 suture had the peek eyelet break into pieces during insertion of the implant.All pieces were retrieved from the patient.The case was completed with another ar-2324kbcsp 4.75 mm biocomposite knotless swivelock anchor without issues.The case was delayed less than 15 minutes with no added anesthesia administered to the patient.No adverse effects were reported.This was discovered during a rotator cuff shoulder scope procedure on (b)(6) 2025, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted the eyelet was damaged and broken.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to excessive forces during insertion, misaligned insertion and/or prying/leveraging 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: 21875962
• Report Number: 1220246-2025-01615
• Device Sequence Number: 15428572
• Product Code: MAI
• UDI-Device Identifier: 00888867384538
• UDI-Public: (01)00888867384538(11)241107(17)281031(10)15343969
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 15343969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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