MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP HALF PIN, ORTHEX 6.0X200X60 BUTTON, HA; HALF PIN, HA

Model Number	HP60-200-60B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Orthex pin broke on the patient.

• Brand Name: HALF PIN, ORTHEX 6.0X200X60 BUTTON, HA
• Common Device Name: HALF PIN, HA
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN 46582
• MDR Report Key: 16138744
• Report Number: 3006460162-2023-00001
• Device Sequence Number: 20500585
• Product Code: JDW
• UDI-Device Identifier: 00841132177624
• UDI-Public: 00841132177624
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K132820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/11/2023

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: HP60-200-60B
• Device Catalogue Number: 01-1501-0128
• Device Lot Number: 213204-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 4 YR
• Patient Sex: Male