MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAG TIGHTROPE II WITH INTERNALBRACE; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAG TIGHTROPE II WITH INTERNALBRACE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/21/2026
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 27-jan-2026, a sales representative reported via phone that an ar-4551 sutureloc, and an ar-1588rtt2-ib fibertag® tightrope failed during use.This occurred during an acl reconstruction on (b)(6) 2026 when the ar-4551 sutureloc anchor pulled through the tibia.The ar-1588rtt2-ib fibertag® tightropes suture broke at the button.All portions of the ar-4551 were removed from the patient, while the suture from the ar-1588rtt2-ib was attached to the graft and remains in the patient, but the button was removed.The procedure continued using devices from another manufacturer.This event resulted in approximately a 30-minute delay, and it is unknown if additional anesthesia was administered.The patient had poor bone quality, and the bone was prepped with the kit's drill.There were no adverse effects on the patient.

• Brand Name: FIBERTAG TIGHTROPE II WITH INTERNALBRACE
• 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: 24331999
• Report Number: 1220246-2026-00570
• Device Sequence Number: 4812663
• Product Code: MBI
• UDI-Device Identifier: 00888867426689
• UDI-Public: (01)00888867426689(11)250807(17)300731(10)15479434
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• 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): 05/29/2026

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: FIBERTAG TIGHTROPE II WITH INTERNALBRACE
• Device Catalogue Number: AR-1588RTT2-IB
• Device Lot Number: 15479434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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