MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 10MM X 320MM ADOLESCENT NAIL, LEFT

Model Number	00-1503-1032
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient has mccune-albright syndrome with polyostotic fibrous dysplasia.Pathologic fracture in 2016 and 2017 both treated with spica casts.On (b)(6) 2020patient underwent osteotomies of his left proximal and distal femur and a fd rod was implanted.On (b)(6) 2023 the fd rod was exchanged for a pnp femoral nail.On (b)(6) 2024 the rigid nail was exchanged due to hardware failure secondary to being pushed down at school.Was doing well on (b)(6) 2025 but fell while in china and returned to clinic 5-6-25 where x-rays showed the rigid nail had broken through the proximal transverse screw hole.

• Brand Name: 10MM X 320MM ADOLESCENT NAIL, LEFT
• Common Device Name: 10MM X 320MM ADOLESCENT NAIL, LEFT
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 22328164
• Report Number: 3006460162-2025-00036
• Device Sequence Number: 9436617
• Product Code: HSB
• UDI-Device Identifier: 00841132146873
• UDI-Public: 00841132146873
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/25/2025

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: 00-1503-1032
• Device Lot Number: 249419-D
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 44 KG