MAUDE Adverse Event Report: TTBIO CORP HENRY SCHEIN; HANDPIECE

Model Number	MAXIMA PRO 2L AR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Handpiece burst in patients mouth leading to minor injury.
Additional Manufacturer Narrative
Handpieces were received on 03/21/24 and evaluated on (b)(6) 2024.Initial report was amended to include evaluation results, see attached amended formal investigation report.
Event or Problem Description
Handpiece burst in patients mouth leading to minor injury.

• Brand Name: HENRY SCHEIN
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 18903664
• Report Number: 3007007357-2024-00005
• Device Sequence Number: 7919399
• Product Code: EFB
• UDI-Device Identifier: 00304040133682
• UDI-Public: (01)00304040133682
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/22/2024
• Report Date (Section F): 03/22/2024

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/15/2024
• Device Age: 14 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/25/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/26/2024
• 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: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/22/2024