MAUDE Adverse Event Report: BRASSELER USA; H33.11.021 #703 44.5MM FE TAPER STRAIGHT SHANK 1

Catalog Number 001221S1

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

Three different oral surgery doctors in the same practice were using the burs for extractions.The burs were breaking at the shank/neck juncture with multiple patients over about a week.There were no injuries.

• Type of Device: H33.11.021 #703 44.5MM FE TAPER STRAIGHT SHANK 1
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• MDR Report Key: 12393513
• MDR Text Key: 270800709
• Report Number: 1032227-2021-00022
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 08/30/2021

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: 001221S1
• Device Lot Number: LR4FE AND/OR LT3MZ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1