MAUDE Adverse Event Report: ORTHOPEDIATRICS 9MM X 340MM ADOLESCENT NAIL, RIGHT

Model Number	00-1504-0934
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) from the (b)(6) reported a post-operative issue involving a 17-year-old female patient implanted with a 9x360 pnp adolescent right nail (part no.00-1504-0935).During a clinic visit, the patient reported femoral pain near the incision site.Imaging revealed a broken nail at the transverse screw hole.A revision procedure was performed, and the device was removed on (b)(6) 2025.

• Brand Name: 9MM X 340MM ADOLESCENT NAIL, RIGHT
• Common Device Name: ADOLESCENT NAIL, RIGHT
• Manufacturer (Section D): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOOEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 23076858
• Report Number: 3006460162-2025-00054
• Device Sequence Number: 4748886
• Product Code: HSB
• UDI-Device Identifier: 00841132146811
• UDI-Public: 00841132146811
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 00-1504-0934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female