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

Model Number	K-LESS T-ROPE W/DRV, SYN REPR, TI
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 13-feb-2026, a sales representative reported via email that an ar-8925t syndesmosis tightrope xp, titanium experienced an issue during use.During a right ankle fracture procedure performed on (b)(6) 2026, a 1/3 tubular plate had been fixated to the bone.A 3.7 mm drill was used to create a hole across the distal tibia and fibula, and the ar-8925t device was inserted from lateral to medial and deployed.Upon tensioning, the lateral button failed to reduce to the bone due to what appeared to be a knot located medial to the lateral button.Attempts to loosen the knot were unsuccessful, preventing proper tensioning of the device.The knotted tightrope xp was cut and removed from the patient.The case was then completed using a replacement ar-8925t syndesmosis tightrope xp, titanium, without further issues.No patient harm was reported.Additional information was received on 19-feb-2026: the knot was immediately identified.When tension was applied, the knot began to further ball up between the button and the bone.The medial side of the ankle was already surgically open, allowing the surgeon to directly visualize the issue without the use of fluoroscopy.The implant was removed, and the procedure was completed using a replacement ar-8925t syndesmosis tightrope xp from a different lot.The case was delayed approximately five minutes, and no additional anesthesia was required.The patient¿s bone was described as very hard.The instruments used included the k-wire and 3.7 mm drill bit provided in the tightrope xp kit.
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, TI
• 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: 24531641
• Report Number: 1220246-2026-01282
• Device Sequence Number: 9026883
• Product Code: HTN
• UDI-Device Identifier: 00888867281608
• UDI-Public: (01)00888867281608(11)251007(17)300930(10)15509923
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/24/2026

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, TI
• Device Catalogue Number: AR-8925T
• Device Lot Number: 15509923
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown