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

Model Number	MAXIMA PRO 2L AR
Medical Device Problem Codes	Accessory Incompatible (1004); Component Incompatible (1108)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Bur used in handpiece bent while in use and injured patient.

• Brand Name: HENRY SCHEIN
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer (Section G): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer Contact: jun li ; 2f., no.7, 6th road; industry park; taichung, 40755
• MDR Report Key: 19236008
• Report Number: 3010364969-2024-00008
• Device Sequence Number: 7996956
• Product Code: EFB
• UDI-Device Identifier: 00304040133682
• UDI-Public: (01)00304040133682
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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 2L AR
• Device Catalogue Number: 570-2094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female