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

Model Number	FIBERTAG TIGHTROPE II
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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 07/17/2025, a sales representative reported via email that an ar-1588rtt2 fibertag tightrope ii implant encountered an issue during a quadruple acl reconstruction procedure performed on (b)(6) 2025.During graft preparation, an ar-1588rtt2 and ar-1588tnt2 device were used.The graft was successfully shuttled into the patient's knee, and the tightrope button was flipped onto the femoral cortex.However, when the surgeon attempted to toggle the white strands of the tightrope to advance the graft into the femoral tunnel, the strands toggled back and forth without moving the graft.Upon further inspection, it was determined that the locking mechanism on top of the button had failed and pulled through, preventing successful graft placement.As a result, the graft had to be removed through the tibial tunnel, and the button was retrieved from the lateral aspect of the patient's knee.A new ar-1588rtt2 device was opened, the quad tendon graft was re-prepared, and the procedure was able to proceed without further complication.Additional information was received on 07/29/2025: the surgery was briefly delayed due to re-preparation of the graft, adding 15¿20 minutes to the case and requiring additional anesthesia.The locking mechanism was correctly engaged before toggling, with proper implant function confirmed outside the body.Graft placement followed standard acl technique, with appropriate tension applied during preparation and insertion.No adverse effects reported on or after surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection noted that blue suture tape was cut and the tightrope was frayed/damaged.An extra green suture was returned but it's a component of the arthrex device.Functional testing was not performed due to the damage to the device.Per dfu-0147.G.Precautions 1.Acl/pcl/btb/rt/abs 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 most likely cause can be attributed to user error, as excessive force on the shortening suture strands may break the strands and impair the ability to fully seat the implant and/or improper surgical technique during use.

• Brand Name: FIBERTAG TIGHTROPE II
• 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: 22730360
• Report Number: 1220246-2025-03291
• Device Sequence Number: 13047346
• Product Code: MBI
• UDI-Device Identifier: 00888867426672
• UDI-Public: (01)00888867426672(11)250502(17)300430(10)15430060
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: FIBERTAG TIGHTROPE II
• Device Catalogue Number: AR-1588RTT2
• Device Lot Number: 15430060
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown