MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 9MM X 380MM ADOLESCENT NAIL, RIGHT

Model Number	00-1504-0938
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
9x380 right adolescent nail broke when removing.This caused a dealy of greater than 30 mins on removal.

• Brand Name: 9MM X 380MM ADOLESCENT NAIL, RIGHT
• Common Device Name: 9MM X 380MM ADOLESCENT NAIL, RIGHT
• 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: 22409182
• Report Number: 3006460162-2025-00037
• Device Sequence Number: 9796093
• Product Code: HSB
• UDI-Device Identifier: 00841132146835
• UDI-Public: 00841132146835
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/06/2025

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: 00-1504-0938
• Device Lot Number: 188435-C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Other
• Patient Sex: Female