MAUDE Adverse Event Report: TTBIO CORP. MAXIMA PRO 2 HP STD. HEAD; HANDPIECE

Model Number	MAXIMA PRO 2 HP STD HEAD
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Handpeice head exploded while being used in a patient's mouth and broke apart.No harm to the patient.
Additional Manufacturer Narrative
Ammended formal investigation report 01/19/2024.See attached documentation.
Event or Problem Description
Handpeice head exploded while being used in a patient's mouth and broke apart.No harm to the patient.

• Brand Name: MAXIMA PRO 2 HP STD. HEAD
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 2f, 7, 6th road; industry pa, taichung 40755 ; TW 40755
• MDR Report Key: 18449927
• Report Number: 3007007357-2024-00001
• Device Sequence Number: 15212084
• Product Code: EFB
• UDI-Device Identifier: 00304040090046
• UDI-Public: 0100304040090046
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024
• Report Date (Section F): 01/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: MAXIMA PRO 2 HP STD HEAD
• Device Catalogue Number: 570-1072
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/07/2023
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/05/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/04/2024