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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 09 mar 2026, it was reported by an arthrex employee via email that ar-8925t k-less t-rope w/drv, syn repr, ti batch 15502038 was pulled out in its whole construct when tugging in the lateral direction to flush the oblong medial button to bone.Possibly due to catching soft tissues on the medial side by the oblong button, causing improper sitting of oblong button.This was detected during ankle fracture & syndesmosis tightrope procedure on (b)(6) 2026.No fragments retained in the patient¿s body and procedure was completed successfully.
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: 24705689
• Report Number: 1220246-2026-01688
• Device Sequence Number: 10109703
• Product Code: HTN
• UDI-Device Identifier: 00888867281608
• UDI-Public: (01)00888867281608(11)250922(17)300831(10)15502038
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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, TI
• Device Catalogue Number: AR-8925T
• Device Lot Number: 15502038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• 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