MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP HALF PIN, ORTHEX 4.5X200X35 BUTTON, HA

Model Number HP45-200-35B

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

4.5mm half pin broke off in the patient at the screw to shank interface.

• Brand Name: HALF PIN, ORTHEX 4.5X200X35 BUTTON, HA
• Type of Device: HALF PIN
• 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: 12514924
• MDR Text Key: 273769429
• Report Number: 3006460162-2021-00038
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HP45-200-35B
• Device Lot Number: 10245
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 45