MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.3MM DRILL BIT, CALIBRATED, AO

Model Number 01-1503-0019

Device Problem Dull, Blunt (2407)

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

Event Date 04/08/2022

Event Type  malfunction  

Event Description

This drill bit has no cutting point, shallow flutes, deflects off the correct path for the screw hole and burns bone.Multiple attempts were made to get the screw through the nail.Multiple drill bits were required due to the burnt bone incarcerated in the drill bit.This caused a delay greater than 30 mins.

• Brand Name: 4.3MM DRILL BIT, CALIBRATED, AO
• Type of Device: DRILL BIT
• 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: 14453602
• MDR Text Key: 300330536
• Report Number: 3006460162-2022-00009
• Device Sequence Number: 1
• Product Code: HTW
• 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
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 01-1503-0019
• Device Catalogue Number: 01-1503-0019
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 73 KG