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

Model Number MAXIMA PRO 2 HP STD HEAD

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

Handpeice head exploded while being used in a patient's mouth and broke apart.No harm to the patient.

Manufacturer Narrative

Ammended formal investigation report 01/19/2024.See attached documentation.

Event 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
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 2f, 7, 6th road; industry pa, taichung 40755 ; TW 40755
• MDR Report Key: 18449927
• MDR Text Key: 332168879
• Report Number: 3007007357-2024-00001
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00304040090046
• UDI-Public: 0100304040090046
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024,01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 01/04/2024
• Distributor Facility Aware Date: 12/07/2023
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female