MAUDE Adverse Event Report: TTBIO CORP. HENRY SCHEIN; HANDPIECE

Model Number	MAXIMA PRO 2 HP STD. HEAD
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The handpiece exploded while it was being used on the patient.The patient was uninjured.
Event or Problem Description
The doctor states the handpiece broke off in the patients mouth and cut them.
Event or Problem Description
The doctor states the handpiece broke off in the patients mouth and cut them.

• Brand Name: HENRY SCHEIN
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; ttbio corp.; 2f, no. 7, 6th road; industrial park, taichung 40755 ; TW 40755
• MDR Report Key: 20362040
• Report Number: 3007007357-2024-00028
• Device Sequence Number: 8097543
• Product Code: EFB
• UDI-Device Identifier: 00304040090046
• UDI-Public: (01)00304040090046
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Exemption Number: 002
• 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,Followup,Followup
• Report Date (Section B): 12/26/2024
• Report Date (Section F): 11/01/2024

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: MAXIMA PRO 2 HP STD. HEAD
• Device Catalogue Number: 570-1072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/03/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/04/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/01/2024; 12/26/2024
• 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: 81 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/01/2024