MAUDE Adverse Event Report: BRASSELER USA KS1 (SC) RD CYL 35005.31.052; DIAMOND BUR

Catalog Number 015562U0

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2021

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 reported that the burs were breaking at the neck of the bur on initial use during a procedure.The burs were used in a kavo hand piece.No burs were returned to brasseler for evaluation.

• Brand Name: KS1 (SC) RD CYL 35005.31.052
• Type of Device: DIAMOND BUR
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• MDR Report Key: 12659926
• MDR Text Key: 279787677
• Report Number: 1032227-2021-00028
• Device Sequence Number: 1
• Product Code: DZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/19/2021

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: LT2MF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1