MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE; BIO SOFT TISSUE FIXATN FASTNR

Model Number	4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
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 11/12/2025, a sales representative reported via (b)(4) that the eyelet of an ar-2324kbcct knotless biocomposite swivelock anchor fractured and snapped in half while loading two suturetape sutures.The anchor was not overloaded with suture and was loaded correctly using the megaloader.As a result, a new anchor was opened and used.This issue was identified during a rotator cuff repair procedure (b)(6) 2025.Additional information was received on 11/17/2025: this issue occurred during preparation.All detached pieces were accounted for.The case was completed with a replacement ar-2324kbcct knotless biocomposite swivelock anchor.There was no case delay or added anesthesia administered to the patient.No adverse effects were reported for this event.No photos were taken of the event.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.The most likely cause of the reported and observed failure is user error.This included misaligned insertion and/or prying or levering the device during insertion, resulting in the device breaking or being damaged.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• 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: 23694979
• Report Number: 1220246-2025-05315
• Device Sequence Number: 9152911
• Product Code: MAI
• UDI-Device Identifier: 00888867351127
• UDI-Public: (01)00888867351127(11)250616(17)290531(10)15452040
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• 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): 03/12/2026

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: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Device Catalogue Number: AR-2324KBCCT
• Device Lot Number: 15452040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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