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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1220246-2024-00521
• Device Sequence Number: 12743307
• Product Code: HTY
• UDI-Device Identifier: 00888867334908
• UDI-Public: 00888867334908
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K200068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown