MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 7MM X 220MM CHILD NAIL, LEFT

Catalog Number	00-1501-0722
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Nail was implanted in spain by doctor moraleda.Breakage of the nail was discovered by dr (b)(4) in dubai and patient is scheduled for removal on (b)(6) 2024.

• Brand Name: 7MM X 220MM CHILD NAIL, LEFT
• Common Device Name: 7MM X 220MM CHILD 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: 20356099
• Report Number: 3006460162-2024-00049
• Device Sequence Number: 8127130
• Product Code: HSB
• UDI-Device Identifier: 00841132146101
• UDI-Public: 00841132146101
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 10/02/2024

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 Catalogue Number: 00-1501-0722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 10/02/2024
• 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: Required Intervention
• Patient Sex: Male