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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/30/2025, a sales representative reported via phone that an ar-8925t syndesmosis tightropes tightening suture had snapped.This occurred during an ankle fracture on 04/30/2025 while being inserted into the patient, and all fragments were retrieved.There was no harm to the patient.The procedure proceeded using another ar-8925t.
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.The complaint device was not received for evaluation.Based on the information provided¿which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data¿arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically, the application of excessive force during suture tensioning and/or adjusting the suture against a sharp or rough edge may result in suture breakage.A slow, steady pull is recommended to ensure the anchor seats properly.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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: 22044920
• Report Number: 1220246-2025-02098
• Device Sequence Number: 8781565
• Product Code: HTN
• UDI-Device Identifier: 00888867281608
• UDI-Public: (01)00888867281608(11)250321(17)300228(10)15407727
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/07/2025

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, TI
• Device Catalogue Number: AR-8925T
• Device Lot Number: 15407727
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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