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

Model Number 01-1500-024

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

Duriing surgery, when the surgeon used the drill, the drill broke.

• Brand Name: 3.2 MM DRILL BIT
• Type of Device: SURGICAL 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: 11455314
• MDR Text Key: 239777412
• Report Number: 3006460162-2021-00004
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• 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: 91704158J
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR