MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 2.5MM DRILL BIT; SURGICAL DRILL BIT

Model Number 01-1050-0002

Device Problem Fracture (1260)

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

Event Date 09/01/2020

Event Type  malfunction  

Event Description

When the surgeon was making a hole to put the screw, the drill broke.No pieces of drill remained inside the patient.

• Brand Name: 2.5MM 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: 11220101
• MDR Text Key: 241248021
• Report Number: 3006460162-2020-00111
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 01-1050-0002
• Device Lot Number: 91801950-J
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 01/23/2021
• 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
• Patient Age: 12 YR