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 Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion; however, due to the device not being returned, we are unable to confirm the reported event.

Event Description

On 6/6/2022, it was reported by a sales representative via phone that (2) ar-8925ss syndesmosis tightrope suture broke during tensioning.A third syndesmosis tightrope was used to complete the case without further issues.This was discovered during an ankle fracture procedure on (b)(6) 2022.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18660995
• MDR Text Key: 334784381
• Report Number: 1220246-2024-00834
• Device Sequence Number: 1
• Product Code: HTN
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 14941896
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1