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

Model Number	ACL TIGHTROPE WITH FIBERTAG, ABS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2026
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 17 february 2026, it was reported by a sales representative via email that an ar-1588tnt, acl tightrope with fibertag abs was reported to have failed during use.It was reported that acl fibertag tightrope abs implant snapped during tensioning at the tibia.According to the representative, the surgeon was not using excessive force during the implant malfunction.This occurred on (b)(6) 2026 during an acl reconstruction, quad graft.The case was completed successfully using an alternative technique to complete repair.There was case involvement.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG, ABS
• 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: 24556772
• Report Number: 1220246-2026-01312
• Device Sequence Number: 15807993
• Product Code: MBI
• UDI-Device Identifier: 00888867308466
• UDI-Public: (01)00888867308466(11)250820(17)300731(10)15485723
• 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,Followup
• Report Date (Section B): 06/24/2026

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: ACL TIGHTROPE WITH FIBERTAG, ABS
• Device Catalogue Number: AR-1588TNT
• Device Lot Number: 15485723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• 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