MAUDE Adverse Event Report: BRASSELER USA 35005.31.052 KS1 SC KOIS; DIAMOND BURS

Catalog Number 015562U0

Device Problem Break (1069)

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

Event Date 06/03/2021

Event Type  malfunction  

Event Description

The doctor was using the ks1 burs for crown prepping.The burs are breaking off and the shanks are getting stuck in their handpieces.The handpieces had to be repaired and have the broken bur shank removed from the handpiece.There were no patients injured, but they did have to suction the broken pieces from the patients' mouths.The doctor did not use a rubber dental dam.

• Brand Name: 35005.31.052 KS1 SC KOIS
• Type of Device: DIAMOND BURS
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• Manufacturer Contact: rod rylands ; 1 brasseler blvd; savannah, GA 31419 ; 4253087468
• MDR Report Key: 12079875
• MDR Text Key: 261510099
• Report Number: 1032227-2021-00011
• Device Sequence Number: 1
• Product Code: DZP
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 06/28/2021

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: 015562U0
• Device Lot Number: LQ4V3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/28/2021
• Type of Device Usage: N
• Patient Sequence Number: 1