MAUDE Adverse Event Report: BRASSELER USA CARBIDE BUR; H34L.31.012 FG CHICKLET

Catalog Number 019425U2

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Brasseler is reporting this alleged product malfunction in an abundance of caution.The allegations of malfunction have not been confirmed due to the inability of brasseler to perform an investigation of the broken burs which were not returned by the customer.Brasseler will follow up with a supplemental report if more information becomes available.

Event Description

The doctor went through 10 carbide burs trying to remove a crown and all of the burs broke.The broken burs were thrown away.

• Brand Name: CARBIDE BUR
• Type of Device: H34L.31.012 FG CHICKLET
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• MDR Report Key: 12413179
• MDR Text Key: 271028459
• Report Number: 1032227-2021-00023
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 019425U2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1