MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS; WASHER, BOLT, NUT

Model Number KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/27/2022

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 5/31/2022, it was reported by a sales representative via phone that while using (2) ar-8926t knotless tightrope syndesmosis repair implant system, the sutures broke consecutively while cinching down.Everything was removed from the patient and surgeon opened an ar-8926ss knotless tightrope syndesmosis repair implant system.At this point, the same thing happened, the suture broke while tensioning and cinching down.Surgeon was able to complete the case with another ar-8926ss knotless tightrope syndesmosis repair.This was discovered during an ankle fracture on (b)(6) 2022.

• Brand Name: KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,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: 18418697
• MDR Text Key: 331603628
• Report Number: 1220246-2023-09771
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867049079
• UDI-Public: 00888867049079
• 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: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
• Device Catalogue Number: AR-8926SS
• Device Lot Number: 25812
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2022
• 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