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	Insufficient Information (4580)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/17/2022, it was reported by a sales representative via email that an ar-4159-16d dynanite 1.6 dbl tip niti g-wire broke post op inside a patient right foot.The original procedure took place on (b)(6) 2022.Currently, the broken g-wire remains in the patient.Additional information requested.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed upon review of the customer-provided x-rays, which identify the broken device within the foot.The most likely cause for the reported failure can be attributed to a patient-specific event.As the ar-4159-16d was not returned for physical analysis and remains in the patient.No change in harm was identified.

• 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: jared engle ; 8009337001
• MDR Report Key: 19230353
• Report Number: 1220246-2024-02709
• Device Sequence Number: 14916640
• Product Code: HTY
• UDI-Device Identifier: 00888867334908
• UDI-Public: 00888867334908
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K200068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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