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	Insufficient Information (4580)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), it was reported by a sales representative via email that an ar-8925ss syndesmosis tightrope xp suture broke prematurely during tensioning.The implant was removed from the patient.This issue was discovered during a syndesmosis repair procedure on (b)(6).Additional information was received on (b)(6): two ar-8925ss syndesmosis tightrope xp devices experienced premature suture breakage during tensioning.Two additional ar-8925ss devices were opened to complete the procedure, and the procedure continued without further issue.The case was delayed by approximately five minutes to remove the broken tightrope and place a new one.No additional anesthesia was required.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 24607433
• Report Number: 1220246-2026-01426
• Device Sequence Number: 10164246
• Product Code: HTN
• UDI-Device Identifier: 00888867281615
• UDI-Public: 00888867281615
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/08/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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