MAUDE Adverse Event Report: BRASSELER USA ASP LG CRN CUT; CARIDE BUR

Catalog Number 019425U2

Device Problem Break (1069)

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

Event Date 08/03/2021

Event Type  malfunction  

Event Description

The heads of the burs were snapping off while cutting through metal crown at the edge where they get jagged.The customer did not save the broken pieces.There were no injuries.

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 burs which were not returned by the customer.Brasseler has conducted a thorough review of 3 years of data on similar devices and no trend has emerged.Brasseler will follow up with a supplemental report if more information becomes available.

• Brand Name: ASP LG CRN CUT
• Type of Device: CARIDE BUR
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• MDR Report Key: 12376930
• MDR Text Key: 280592373
• Report Number: 1032227-2021-00020
• 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: health professional
• Type of Report: Initial
• Report Date: 08/27/2021

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: No Information
• Device Catalogue Number: 019425U2
• Device Lot Number: LR5AC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1