MAUDE Adverse Event Report: TTBIO CORP BRASSELER; HANDPEICE

Model Number	BRIO 440F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The back cap and turbine with bur broke apart in the patient's mouth.

• Brand Name: BRASSELER
• Common Device Name: HANDPEICE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 21911454
• Report Number: 3007007357-2025-00004
• Device Sequence Number: 21093049
• Product Code: EFB
• UDI-Device Identifier: 00887919821670
• UDI-Public: (01)00887919821670
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/25/2025
• Report Date (Section F): 04/25/2025

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
• Operator of Device: Health Professional
• Device Model Number: BRIO 440F
• Device Catalogue Number: 5026480U0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2025
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/25/2025