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

Model Number 01-1500-024

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

During the surgery the drill broke, the surgeon was able to remove the fragment of the drill from the bone.

• Brand Name: 3.2 MM DRILL BIT
• 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: 12084596
• MDR Text Key: 261693050
• Report Number: 3006460162-2021-00022
• 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
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 01-1500-024
• Device Lot Number: 91300674-J
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 55