MAUDE Adverse Event Report: BRASSELER USA TELESCOPINT ROUND DIAMOND; DIAMOND BUR

Catalog Number BR5820-012-050

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

Brasseler is reporting this incident in an abundance of caution due to user error.

Event Description

On the laminectomy portion of the procedure the surgeon was struggling to burr the bone.After a bit of burring, the burr got extremely hot.When irrigation was splashed on the burr tip, it sizzled.This patient has very delicate, soft bone, so the surgeon could not keep burring without causing more harm.The surgeon was able to continue by using a cutting burr instead.

• Brand Name: TELESCOPINT ROUND DIAMOND
• Type of Device: DIAMOND BUR
• 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: 19166063
• MDR Text Key: 340851225
• Report Number: 2025102-2024-00002
• Device Sequence Number: 1
• Product Code: DZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BR5820-012-050
• Device Lot Number: NX5B3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White