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

Model Number	FIBERTAG TIGHTROPE II WITH INTERNALBRACE
Medical Device Problem Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
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 (b)(6) 2025, it was reported by a sales representative via email that an ar-1588rtt2-ib fibertag tightrope ii with internalbrace experienced a failure on the femoral side.After docking the femoral graft and completing the let portion of the procedure using knee fibertak implants, the surgeon returned to perform the final tensioning on the tibial side and noted that the graft had pulled out of the femoral socket.It was observed that the femoral button was loose, and the tightrope appeared to be ruptured.The graft was removed, re-prepared with new femoral and tibial implants, and re-implanted.This added approximately 45¿60 minutes to the procedure; however, the case was completed without complications and with good final graft integrity and fixation.This was discovered during a revision acl reconstruction procedure on (b)(6) 2025.Additional information was received on 22-dec-2025: the issue occurred inside the patient and was identified after completion of tibial tensioning during a revision acl reconstruction procedure.Following the failure of the tightrope and button, they were removed from the patient prior to proceeding with new implants.The case was completed using a replacement ar-1588rtt2-ib fibertag tightrope ii with internal brace.Additional anesthesia was administered to allow for the removal of the graft, re-preparation, and re-implantation, extending the operative time by approximately 45 minutes.The original surgery was a bone¿tendon¿bone acl reconstruction utilizing bio composite interference screws.The date of the original procedure is unknown, and it was performed at a different facility by a different surgeon.There were no arthrex products implanted during the original surgery; however, the bio composite interference screws appeared well resorbed in the patient.No arthrex products were removed during the revision procedure.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.Directions for use dfu-0147-eo revision 4.Tightrope devices.G.Precautions: 1.Acl/pcl/btb/rt/abs/cl/cls/pf/pfc tightrope only: excessive force on the shortening suture strands and/or tensioning the shortening suture strands not in-line with the bone socket may break the strands and impair the ability to fully seat the implant.No additional force on the shortening suture strands is required when the graft/wedge construct reaches the desired position in the femoral socket, and the graft stability is verified by pulling distally on the graft.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: FIBERTAG TIGHTROPE II WITH INTERNALBRACE
• 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: 23974970
• Report Number: 1220246-2026-00077
• Device Sequence Number: 10621401
• Product Code: MBI
• UDI-Device Identifier: 00888867426689
• UDI-Public: (01)00888867426689(11)250716(17)300630(10)15467557
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: FIBERTAG TIGHTROPE II WITH INTERNALBRACE
• Device Catalogue Number: AR-1588RTT2-IB
• Device Lot Number: 15467557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown