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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2022

Event Type  malfunction  

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.

Event Description

On (b)(6) 2022, it was reported by a sales representative via email that a total of four ar-8925t syndesmosis tightrope broke at the round lateral button during the final tightening.Surgeon removed all failed hardware and had to make a medial incision in order to retrieve the buttons.This caused a significant delay in the procured.Case was completed using a syndesmosis screw.This was discovered during an ankle fracture procedure on (b)(6) 2022.

Manufacturer Narrative

The tightrope breakage is confirmed upon review of the customer-provided photo.However, as the devices were not returned for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: K-LESS T-ROPE W/DRV, SYN REPR, TI
• 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: 14194189
• MDR Text Key: 290053464
• Report Number: 1220246-2022-04792
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867281608
• UDI-Public: 00888867281608
• 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,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: K-LESS T-ROPE W/DRV, SYN REPR, TI
• Device Catalogue Number: AR-8925T
• Device Lot Number: 14921880
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2022
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other