MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE® II RT, RECON IB¿; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE® II RT, RECON IB¿
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 04-feb-2026, an arthrex subsidiary employee reported via email that an ar-1588rt-ib tightrope ii rt experienced an issue during a procedure on (b)(6) 2026.After graft passage, the adjustment loop was pulled; however, the chinese finger trap mechanism broke, and the graft did not advance despite additional tension.The procedure may have been delayed by more than an hour, and additional anesthesia may have been required.The surgery was completed using another, unspecified product.Additional information was received on 10-feb-2026: the ar-1588rt-ib tightrope ii rt was removed after the break occurred during the acl reconstruction procedure, and the case was completed using an ar-1588btb-ib tightrope ii btb.The surgery was extended by 45 minutes.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: TIGHTROPE® II RT, RECON IB¿
• 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: 24402267
• Report Number: 1220246-2026-00708
• Device Sequence Number: 21296814
• Product Code: MBI
• UDI-Device Identifier: 00888867291638
• UDI-Public: (01)00888867291638(11)250626(17)300531(10)15456954
• 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): 06/15/2026

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: TIGHTROPE® II RT, RECON IB¿
• Device Catalogue Number: AR-1588RT-IB
• Device Lot Number: 15456954
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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