MAUDE Adverse Event Report: ARTHREX, INC. K-LESS T-ROPE W/DRV, SYN REPR, SS; WASHER, BOLT, NUT

Model Number	K-LESS T-ROPE W/DRV, SYN REPR, SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
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
On 09-mar-2026, a sales representative reported via email that an ar-8925ss syndesmosis tightrope xp broke upon insertion.The surgeon was performing final tensioning when one of the sutures snapped within the implant.The case was completed by leaving the damaged tightrope in place and implanting an additional tightrope one hole higher.Fluoroscopic imaging confirmed no further syndesmotic movement.This issue occurred during a procedure on (b)(6) 2026.No patient harm was reported.Additional information was received on 11-mar-2026: this occurred during an isolated ankle syndesmosis repair procedure.The case was completed using a replacement ar-8925ss syndesmosis tightrope xp.There was no case delay, no additional anesthesia time, and the bone quality was reported as normal.

• Brand Name: K-LESS T-ROPE W/DRV, SYN REPR, SS
• Common Device Name: WASHER, BOLT, NUT
• 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: 24712932
• Report Number: 1220246-2026-01701
• Device Sequence Number: 6013163
• Product Code: HTN
• UDI-Device Identifier: 00888867281615
• UDI-Public: (01)00888867281615(11)250128(17)291231(10)15379715
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K043248
• 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): 07/09/2026

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: K-LESS T-ROPE W/DRV, SYN REPR, SS
• Device Catalogue Number: AR-8925SS
• Device Lot Number: 15379715
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown