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

Device Problems Break (1069); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, it was reported by a facility representative via phone that (2) ar-8925ss tightropes failed.This occurred on (b)(6) 2022 during a orif ankle procedure when the first tightrope broke during use, the fragment was retrieved.A second tightrope was used and would not deploy.The case was completed using a third tightrope along with additional screws, and plates.There was no patient effect reported.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: K-LESS T-ROPE W/DRV, SYN REPR, SS
• Type of Device: 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: vik bajnath ; 8009337001
• MDR Report Key: 14407075
• MDR Text Key: 300227907
• Report Number: 1220246-2022-04905
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867281615
• UDI-Public: 00888867281615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K-LESS T-ROPE W/DRV, SYN REPR, SS
• Device Catalogue Number: AR-8925SS
• Device Lot Number: 13163782
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2022
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1