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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the tightrope suture failed at the locking mechanism.The suture loops tightened fully and the connecting suture over the button snapped meaning sutures were no longer tensioned against the button.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully by using a different technique: a fixed loop femoral fixation.It was not necessary to do a second surgery.
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: 24280626
• Report Number: 1220246-2026-00458
• Device Sequence Number: 12825434
• Product Code: MBI
• UDI-Device Identifier: 00888867291638
• UDI-Public: (01)00888867291638(11)250526(17)300430(10)15441306
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: 15441306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2025
• 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