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

Model Number	TIGHTROPE® II RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/25/2025, a sales representative reported via (b)(4) that an ar-1588rt-2 tightrope when tensioning, the interlinking button fiber rope broke.This issue occurred during case the patient not affected however the was concern because the patient was under anesthesia longer than normal.
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 was provided on 07/31/2025 where it was reported that this event occurred during an acl reconstruction with auto quad graft on (b)(6) 2025.The sutures that bridge over the femoral button broke, so the tightrope was no longer self sinching or knotless.The patient had good bone quality.The bone socket was prepared via all inside standard technique with flipcutter 3.No problems occurred when preparing bone socket.There were no fragments that needed to be retrieved out of patient because it was just suture breaking.An additional abs 11mm button was used to complete the procedure and tie the tightrope over this button on the femoral side.This caused about a 30-minute delay in the procedure, the patient spent longer time under anesthesia.The complaint device still remains in the body.They had to use the tightrope in an un- ideal fashion by tying knots and manually sinching the tension.
Additional Manufacturer Narrative
Additional information: b5, 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 applying excessive mechanical forces upon insertion.Dfu-0147-eo: 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 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 could not be confirmed as we did not receive the device for investigation.

• Brand Name: TIGHTROPE® II RT
• 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: 22787309
• Report Number: 1220246-2025-03444
• Device Sequence Number: 21299507
• Product Code: MBI
• UDI-Device Identifier: 00888867319707
• UDI-Public: 00888867319707
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• 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
• Report Date (Section B): 12/12/2025

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 RT
• Device Catalogue Number: AR-1588RT-2
• Device Lot Number: 15384158
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown