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 Codes	Break (1069); Crack (1135)
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.Complaint allegation is not confirmed.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 and the quality of the bone encountered were not specified.The most likely cause of 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 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: 23042900
• Report Number: 1220246-2025-03842
• Device Sequence Number: 9832427
• Product Code: MAI
• UDI-Device Identifier: 00888867384514
• UDI-Public: 00888867384514
• 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): 12/05/2025

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
• Operator of Device: Health Professional
• Device Model Number: SWIVELOCK, SP BC 4.75MM
• Device Catalogue Number: AR-2324BCSP
• 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: 12/04/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown