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

Model Number	SWIVELOCK, SP BC 4.75MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/22/2025, a sales representative reported via email that three ar-2324bcsp biocomposite swivelock anchors experienced cracking when attempting to advance the screw.As a result, they opened three more ar-2324bcsp biocomposite swivelock anchors from lot 15419013 and got similar results.The case was completed without complications using an alternative ar-2324bcsp biocomposite swivelock anchor from a different lot.This issue was identified during a rotator cuff repair procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 08/27/2025.
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.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 most likely cause of the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.Dfu-0362-eo.4.Swivelock only: during anchor insertion, ensure that the angle of the anchor insertion is coaxial to that of the previously prepared bone socket.7.Swivelock only: do not use excessive force when inserting the eyelet into bone to avoid device damage.If device is not advancing after repeated malleting, a pilot hole should be created.If the eyelet becomes unusable after repeated malleting, discard it and use a new implant.8.Ensure that the angle of anchor insertion is perpendicular to the bone.

• Brand Name: SWIVELOCK, SP BC 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: 23039119
• Report Number: 1220246-2025-03832
• Device Sequence Number: 9832303
• Product Code: MAI
• UDI-Device Identifier: 00888867384514
• UDI-Public: (01)00888867384514(11)250410(17)290331(10)15419013
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/19/2026

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 4.75MM
• Device Catalogue Number: AR-2324BCSP
• Device Lot Number: 15419013
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown