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

Model Number	TIGHTROPE® II BTB, RECON IB¿
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2024
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
On 07/31/2024 it was reported by a sales representative via email that an ar-1588btb-ib tightrope ii btb sutures were broken.The surgeon successfully passed the graft, and the button flipped on the femoral cortex.After the graft was tensioned and the fibertape from the internalbrace was inserted with a swivelock, a look into the joint showed that two sutures were ripped.The surgeon cut the tails remaining in the joint and no harm to the patient was done.The surgeon suspects the sutures failed at the button aperture on the femoral side.The button was left implanted in the patient, and the surgeon decided to forgo using the internal brace feature.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 8/5/2024: this was discovered during an aclr procedure.The case was delayed due to the surgeon having to cut the tapes out from the joint.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: TIGHTROPE® II BTB, 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: 19927937
• Report Number: 1220246-2024-07064
• Device Sequence Number: 2725448
• Product Code: MBI
• UDI-Device Identifier: 00888867319677
• UDI-Public: 00888867319677
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K231857
• 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,Followup,Followup
• Report Date (Section B): 06/23/2025

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 BTB, RECON IB¿
• Device Catalogue Number: AR-1588BTB-IB
• Device Lot Number: 15242125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 08/05/2024; 06/09/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/28/2024; 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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