MAUDE Adverse Event Report: ORTHOPEDIATRICS 9MM X 360MM ADOLESCENT NAIL, RIGHT

Model Number	00-1504-0936
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) from (b)(6) reported a post-operative issue involving a 10-year-old male patient implanted with a 9mm x 360mm adolescent right nail (part no.00-1504-0936).During a clinic visit, the nail was found broken through the most proximal screw hole of the distal portion.A revision procedure was performed, and the device was removed on (b)(6) 2025.The hospital disposed of the broken device, and it is not available for evaluation.No patient injury or death was reported, and the surgery was completed successfully.

• Brand Name: 9MM X 360MM 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: 23077457
• Report Number: 3006460162-2025-00057
• Device Sequence Number: 15905656
• Product Code: HSB
• UDI-Device Identifier: 00841132146828
• UDI-Public: 00841132146828
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 00-1504-0936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• 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: 10 YR
• Patient Sex: Male