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	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/21/2025, it was reported by a sales representative via phone that an ar-8925ss syndesmosis tightrope xp suture broke during tensioning.All broken sutures and the button was removed from the patient.The case was completed with another ar-8925ss syndesmosis tightrope xp from a different lot without issues.There was less than 15 minutes of case delay with no added anesthesia administered to the patient.No adverse effects were reported on or after the surgery.This was discovered during a syndesmosis repair procedure on (b)(6) 2025, with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening/tensioning.

• 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: 21950635
• Report Number: 1220246-2025-01863
• Device Sequence Number: 8800468
• Product Code: HTN
• UDI-Device Identifier: 00888867281615
• UDI-Public: (01)00888867281615(11)250103(17)291231(10)15368277
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/25/2025

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: 15368277
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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