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	07/18/2025
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 7/18/2025, a sales representative reported via phone that an ar-2324kbcsp 4.75 mm biocomposite knotless swivelock anchor had an issue during a rotator cuff repair procedure on (b)(6) 2025.When the surgeon was inserting it into the bone at a perpendicular angle, upon tapping, the eylet broke inside the patient.The surgeon was able to remove all fragments from the patient, and there was no harm.The complaint device was discarded, and no pictures were taken.Another ar-2324kbcsp 4.75 mm biocomposite knotless swivelock anchor with the same lot number was used to complete the procedure successfully.The case was slightly delayed by under 15 minutes, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and/or incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• 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: 22736845
• Report Number: 1220246-2025-03303
• Device Sequence Number: 21112358
• Product Code: MAI
• UDI-Device Identifier: 00888867384538
• UDI-Public: (01)00888867384538(11)250516(17)290430(10)15437557
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/06/2025

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: 15437557
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown