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

Model Number	ACL TIGHTROPE WITH FIBERTAG
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
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 arthroscopy the device tore when inserted into the femoral canal.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-1588rtt batch 15501569 was received for investigation.Visual inspection revealed that the needle was not received for evaluation.The suture loops were passed to the opposite side of the button.Stiffness and damage to the suture were noted.Due to the observed damage, the suture could not be passed to the correct side of the button, and functional testing could not be performed.The most likely cause of the reported failure is user error, specifically incorrect surgical technique associated with the device.Directions for use.Dfu-0147.Tightrope® devices.Precautions.1.Acl/pcl/ btb/rt/abs tightrope only: excessive force on the shortening suture strands may break the strands and impair 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.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG
• 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: 24442620
• Report Number: 1220246-2026-00912
• Device Sequence Number: 10307757
• Product Code: MBI
• UDI-Device Identifier: 00888867308459
• UDI-Public: (01)00888867308459(11)250922(17)300831(10)15501569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 06/04/2026

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: ACL TIGHTROPE WITH FIBERTAG
• Device Catalogue Number: AR-1588RTT
• Device Lot Number: 15501569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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