MAUDE Adverse Event Report: PARAGON28, INC. PHANTOM FIBULA NAIL SYSTEM

Model Number	P36-128-130R-S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint (b)(4).The device was returned and the part and lot number reported was confirmed to match.The complaint is confirmed.The dhr was reviewed.There were no nonconformances or temporary deviations associated with this failure on this lot.The failure is most likely due to manufacturing issues since the threads turn a couple times only and would get stuck; recall: 25-09 was initiated.The action is still under review for recall classification and fda has not completed classification.
Event or Problem Description
The fibular nail did not sit flush or tighten properly to the outrigger when correctly positioned.This resulted in a delay of approximately 30 minutes to troubleshoot the problem.The nail was removed from the patient and upsize to the next size nail to complete the procedure successfully.No report of patient impact.

• Brand Name: PHANTOM FIBULA NAIL SYSTEM
• Common Device Name: PHANTOM FIBULA NAIL SYSTEM
• Manufacturer (Section D): PARAGON28, INC.; 14445 grasslands drive; englewood CO
• Manufacturer (Section G): PARAGON28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: mandy mahlstadt ; 14445 grasslands dr; englewood, CO 80112
• MDR Report Key: 23303569
• Report Number: 3008650117-2025-00002
• Device Sequence Number: 16000677
• Product Code: HSB
• UDI-Device Identifier: 00889795133670
• UDI-Public: (01)00889795133670(10)501182207125
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K234128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: P36-128-130R-S
• Device Catalogue Number: P36-128-130R-S
• Device Lot Number: 501182207125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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