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

Model Number	ACL TIGHTROPE WITH FIBERTAG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 12-feb-2026, an arthrex subsidiary employee reported via email that an ar-1588rtt acl fibertag tightrope implant encountered issues during an acl reconstruction performed on (b)(6) 2026.Passing and flipping were completed without difficulty; however, the surgeon experienced resistance when adjusting the graft into the bone tunnel.The graft was eventually advanced, but two adjustment threads broke during subsequent tensioning.When attempting tibial fixation, the graft backed out in the opposite direction, and the loop was found to be completely broken.The procedure was completed using a non-arthrex device, and no components remained in the patient.No significant surgical delay, additional anesthesia, or patient adverse effects were reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG
• 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: 24519166
• Report Number: 1220246-2026-01239
• Device Sequence Number: 20962905
• Product Code: MBI
• UDI-Device Identifier: 00888867308459
• UDI-Public: (01)00888867308459(11)250714(17)300630(10)15466639
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/23/2026

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
• Device Catalogue Number: AR-1588RTT
• Device Lot Number: 15466639
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown