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

Model Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2023

Event Type  malfunction  

Event Description

4.5mm 1/2 pin broke.

• Brand Name: HALF PIN, ORTHEX BUTTON, HA
• Type of Device: HALF PIN, ORTHEX BUTTON, HA
• 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: 18274790
• MDR Text Key: 329838205
• Report Number: 3006460162-2023-00037
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWNUNKNO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 18 KG