MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 5.5MM BC SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DBL LOADED 5.5MM BC SWVLK
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via (b)(4) that an ar-2323bct-2 biocomposite swivelock c was anchored but had an issue with being unable to remove the inserter and the knob from the sutures at the end.They were able to cut the sutures, and the rep checked the inserter after the case and was able to remove the sutures with hemostats.The rep said the sutures were intact without any knots.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 02/07/2025: this occurred in a rotator cuff repair procedure on (b)(6) 2025.There was no case delay and no added anesthesia administered to the patient.No adverse effects on the patient.
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, h11.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 is attributed to misuse due to misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: DBL LOADED 5.5MM BC SWVLK
• 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: 21412034
• Report Number: 1220246-2025-00549
• Device Sequence Number: 9312081
• Product Code: MAI
• UDI-Device Identifier: 00888867251069
• UDI-Public: (01)00888867251069(11)240605(17)260531(10)15259204
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/25/2025

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: 05/31/2026
• Device Model Number: DBL LOADED 5.5MM BC SWVLK
• Device Catalogue Number: AR-2323BCT-2
• Device Lot Number: 15259204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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