MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 2.9 MM CANNULATED DRILL BIT

Model Number 01-0907-0009

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 10/29/2020

Event Type  malfunction  

Event Description

Drill bit broke in most proximal locking screw hole whilst drilling over 1.6mm guidewire.

• Brand Name: 2.9 MM CANNULATED DRILL BIT
• Type of Device: CANNULATED 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: 11252531
• MDR Text Key: 229834713
• Report Number: 3006460162-2020-00140
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 01-0907-0009
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1