MAUDE Adverse Event Report: BRASSELER USA DENTAL, LLC BRASSELER USA CARBIDE BUR

Model Number H33.36.021

Device Problem Bent (1059)

Patient Problem Injury (2348)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

Bur bent violently during use and injured a patient.Customer currently using the h33.36.021 bur in their nsk ti-max 1:4.2 ratio (which is just under 2000,000 rpm's) impact air handpiece.Customer said it was only a minor cut to the gums.

• Brand Name: BRASSELER USA CARBIDE BUR
• Manufacturer (Section D): BRASSELER USA DENTAL, LLC; one brasseler blvd.; savannah GA 31419
• Manufacturer (Section G): BRASSELER USA I, L.P.; one brasseler blvd.; savannah GA 31419
• Manufacturer Contact: kenneth jones ; one brasseler blvd.; savannah, GA 31419 ; 9129217501
• MDR Report Key: 4620238
• MDR Text Key: 5701240
• Report Number: 1032227-2015-00006
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: H33.36.021
• Device Catalogue Number: 000463U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1