MAUDE Adverse Event Report: ORTHOPEDIATRICS IM FEMORAL NAIL, 9MM X 32CM, RIGHT

Model Number	10-1500-043
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient broke his pedinail within two months time.

• Brand Name: IM FEMORAL NAIL, 9MM X 32CM, RIGHT
• Common Device Name: IM FEMORAL NAIL, 9MM X 32CM, 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: 22764512
• Report Number: 3006460162-2025-00047
• Device Sequence Number: 8133966
• Product Code: HSB
• UDI-Device Identifier: 00841132118832
• UDI-Public: 00841132118832
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/08/2025

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: 10-1500-043
• Device Lot Number: 173800-N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male