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	Insufficient Information (4580)
Date of Event	04/30/2025
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 04/30/2025, it was reported by a sales representative via phone that (2) ar-2324bcsp 4.75 mm biocomposite swivelock® anchors peek eyelets broke.This occurred during a supraspinatus repair on (b)(6)2025, where the proper technique guide was followed.The fragments were retrieved, and the case continued using an ar-2324bcc, and the bone was prepped using a punch.There was a slight delay of about 5 minutes with no additional anesthesia required.
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 field data, arthrex concluded that the most probable contributing factors to the reported failure include improper bone preparation and/or the use of prying or leveraging techniques during device insertion.Since the complaint device was not returned and no evidence of the failure was provided, neither physical inspection nor a review of images could be performed.As a result, the complaint allegation could not be confirmed.

• 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: 22045005
• Report Number: 1220246-2025-02101
• Device Sequence Number: 18369798
• Product Code: MAI
• UDI-Device Identifier: 00888867384514
• UDI-Public: (01)00888867384514(11)250307(17)290228(10)15401480
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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
• Device Lot Number: 15401480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2025
• 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