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

Model Number	FIBERTAG TIGHTROPE II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 of the reported failure can be attributed to user error of the device due to excessive force being used when inserting the button.
Event or Problem Description
On 6th january 2026, it was reported by an arthrex employee via email that for an ar-1588rtt2, fibertag® tightrope® ii implant, the rtt fibertag tightrope snapped at the button after the button had flipped on outer cortex.The surgeon went to dock in graft, and one tail gave way and was unable to tension that side.This was detected during a quads acl procedure on (b)(6) 2026.The procedure was completed successfully as a btb tightrope was used to recreate the tightrope as the tag was fine, only the locking mechanism had failed on one side.

• Brand Name: FIBERTAG TIGHTROPE II
• 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: 24114662
• Report Number: 1220246-2026-00246
• Device Sequence Number: 20318588
• Product Code: MBI
• UDI-Device Identifier: 00888867426672
• UDI-Public: (01)00888867426672(11)250502(17)300430(10)15430060
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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
• Device Catalogue Number: AR-1588RTT2
• Device Lot Number: 15430060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2025
• 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