MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE 1.6 DBL TIP NITI G-WIRE 2 ZONE; SMOOTH FIXATION PIN

Model Number DYNANITE 1.6 DBL TIP NITI G-WIRE 2 ZONE

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

On 3/22/2023, it was reported by a sales representative via email that a flexwire broke proximally inside the patient post-operative.This occurred while the patient was in a cast, walking on it.No further information has been provided.Additional information received on 4/14/2023: this was discovered post-operative of a hammer toe procedure performed on (b)(6) 2023.The patient was bandaged and placed in a walking cast when on (b)(6) 2023, the flexwire broke.Revision surgery has not been scheduled.

Manufacturer Narrative

The device was not received for evaluation and no photo was provided; complaint not confirmed.The most likely probable cause of the event is attributed to a patient-specific event.

• Brand Name: DYNANITE 1.6 DBL TIP NITI G-WIRE 2 ZONE
• Type of Device: SMOOTH FIXATION PIN
• 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: 18579162
• MDR Text Key: 334175034
• Report Number: 1220246-2024-00521
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867334908
• UDI-Public: 00888867334908
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200068
• 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: 01/25/2024

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
• Device Operator: Health Professional
• Device Model Number: DYNANITE 1.6 DBL TIP NITI G-WIRE 2 ZONE
• Device Catalogue Number: AR-4159-16D
• Device Lot Number: 14959077
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• 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