MAUDE Adverse Event Report: ARTHREX, INC. K-LESS T-ROPE IMP ONLY, SYN REPR, SS; WASHER, BOLT, NUT

Model Number	K-LESS T-ROPE IMP ONLY, SYN REPR, SS
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when passing the suture.
Event or Problem Description
It was reported that during a dex procedure, the loop suture was cut when the surgeon was passing the tightrope through the fibula nail.Fragment was retrieved and the case was completed by using a new ar-8924ss.

• Brand Name: K-LESS T-ROPE IMP ONLY, 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: emily shafer ; 8009337001
• MDR Report Key: 19144810
• Report Number: 1220246-2024-02172
• Device Sequence Number: 7548235
• Product Code: HTN
• UDI-Device Identifier: 00888867265592
• UDI-Public: 00888867265592
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2024

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 Expiration Date: 12/31/2025
• Device Model Number: K-LESS T-ROPE IMP ONLY, SYN REPR, SS
• Device Catalogue Number: AR-8924SS
• Device Lot Number: 24119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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