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

Catalog Number	019425U2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: H34L.31.012 FG CHICKLET
• MDR Report Key: 12413179
• Report Number: 1032227-2021-00023
• Device Sequence Number: 15335158
• Product Code: EJL
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 019425U2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: N
• Patient Sequence Number: 1