MAUDE Adverse Event Report: TTBIO CORP BRASSELER BRIO 450L; HANDPIECE

Model Number	BRIO 450L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgical bur came out of handpiece where patient swallowed the bur.

• Brand Name: BRASSELER BRIO 450L
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 18813113
• Report Number: 3007007357-2024-00003
• Device Sequence Number: 4342532
• Product Code: EFB
• UDI-Device Identifier: 00887919872283
• UDI-Public: 0100887919872283
• 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): 02/29/2024
• Report Date (Section F): 02/29/2024

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
• Operator of Device: Health Professional
• Device Model Number: BRIO 450L
• Device Catalogue Number: 5027989U0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/29/2024