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	02/24/2026
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 25-feb-2026, a sales representative reported via email that an ar-8925ss syndesmosis tightrope xp experienced an issue during an ankle fracture repair procedure performed on (b)(6) 2026.While tensioning the tightrope xp, the sutures broke before final fixation could be achieved, and the sutures appeared to have broken at the lateral button.The medial incision had already been made for the associated medial fracture, which allowed the surgeon to remove both the medial and lateral buttons.A new tightrope implant was then opened and used to complete the fixation.No patient harm was reported.Additional information was received on 02-mar-2026: the case was not delayed, and additional anesthesia was not needed.

• 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: 24634535
• Report Number: 1220246-2026-01479
• Device Sequence Number: 15627783
• Product Code: HTN
• UDI-Device Identifier: 00888867281615
• UDI-Public: (01)00888867281615(11)240822(17)290731(10)15306397
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Device Lot Number: 15306397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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