MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ® II RT WITH DEPLOYING SUTURE; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE ® II RT WITH DEPLOYING SUTURE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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
It was reported that during a knee surgery the tightrope buttons came loose when pulling and raising the graft.The surgeon had to repeat the procedure, re-sew the graft, and reattach a button.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation was confirmed.One unpackaged ar-1588rt-2j tightrope® ii rt, with deploying suture batch 15491797, was received for evaluation.Visual inspection revealed that the suture system was broken; the suture attached to the button shows stiffness and bunches close to the button, an indication of excessive force used or incorrect surgical technique.Fray was noted on the suture tail.No sharp edges were noted on the button.Due to damage to the suture system, the functional test was not performed.The most likely cause of the reported failure is attributed to use error, including incorrect surgical technique, application of excessive force to the shortening suture strands, and/or tensioning not aligned with the bone socket, which may result in strand breakage and impaired ability to fully seat the implant.Refer to directions for use (dfu-0147-eo, revision 4), tightrope® devices, section g.Precautions for additional information.

• Brand Name: TIGHTROPE ® II RT WITH DEPLOYING SUTURE
• 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: 24814816
• Report Number: 1220246-2026-02034
• Device Sequence Number: 9686471
• Product Code: MBI
• UDI-Device Identifier: 00888867319714
• UDI-Public: (01)00888867319714(11)250902(17)300831(10)15491797
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/11/2026

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 WITH DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-2J
• Device Lot Number: 15491797
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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