MAUDE Adverse Event Report: Arthrex, Inc. ACL FiberTag® TightRope® Implant System; NON-DEGRADABLE FIXATN FASTENER

Model Number	ACL FiberTag® TightRope® Implant System
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, it was reported by a sales representative via email that an ar-1288qt-100 acl fibertag tightrope was associated with a dull cutting instrument during graft harvest.It was reported that the instrument felt dull when cutting the tendon, resulting in premature cutting of the tendon.The procedure was completed successfully with no pieces breaking off in the patient.This occurred during a quad acl autograft reconstruction procedure performed on (b)(6) 2026.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: ACL FiberTag® TightRope® Implant System
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50474875
• Report Number: 1220246-2026-04510
• Device Sequence Number: 10234455
• Product Code: MBI
• UDI-Device Identifier: 00888867344716
• UDI-Public: (01)00888867344716(11)250701(17)270430(10)15459290
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/27/2026

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 FiberTag® TightRope® Implant System
• Device Catalogue Number: AR-1288QT-100
• Device Lot Number: 15459290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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