MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 3.2MM DRILL BIT CALIBRATED; SUGICAL DRILL BIT

Model Number 01-1200-0041

Device Problem Fracture (1260)

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

Event Date 08/26/2020

Event Type  malfunction  

Event Description

When the surgeon was making a hole to put the screw, the drill broke and a piece remained inside.The surgeon comments that when he remove the plate he will remove the bit of drill.

• Brand Name: 3.2MM DRILL BIT CALIBRATED
• Type of Device: SUGICAL 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: 11203300
• MDR Text Key: 242240036
• Report Number: 3006460162-2020-00110
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-1200-0041
• Device Lot Number: 00U7Q-D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1