MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPLANT SYSTEM, SWIVELOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/16/2025, it was reported by a sales representative via email that an ar-2324bccs biocomposite swivelock anchor broke during insertion.This was discovered during a procedure on (b)(6) 2025.The case was completed using another.Additional information requested on 5/12/2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, 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 can be attributed to misaligned insertion; or prying/leveraging the device during use.
Event or Problem Description
Additional information requested on 5/12/2025.A shoulder rotator cuff repair procedure was performed on 04/16/2025.During the surgery, an issue required opening another anchor, causing a brief delay.All fragments were successfully retrieved.The case was completed using part number ar-2324kbcc.No additional anesthesia was administered to the patient.

• Brand Name: IMPLANT SYSTEM, SWIVELOCK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 22005532
• Report Number: 1220246-2025-02017
• Device Sequence Number: 9201800
• Product Code: MAI
• UDI-Device Identifier: 00888867098015
• UDI-Public: (01)00888867098015(11)231204(17)251031(10)15175049
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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 Expiration Date: 10/31/2025
• Device Model Number: IMPLANT SYSTEM, SWIVELOCK
• Device Catalogue Number: AR-2324BCCS
• Device Lot Number: 15175049
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown