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

Model Number	MAXIMA PRO 2 HP STD HEAD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer advised that the head cap came unscrewed and popped out into patients mouth.No injury to patient or swallowed parts, all parts were retrieved from the patients mouth.

• Brand Name: HENRY SCHEIN
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 3f, no. 7, 6th road industry p; taichung city, taichung 40755 ; TW 40755
• MDR Report Key: 20287346
• Report Number: 3007007357-2024-00025
• Device Sequence Number: 12565055
• Product Code: EFB
• UDI-Device Identifier: 00304040090046
• UDI-Public: (01)00304040090046
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Dentist
• Type of Report: Initial
• Report Date (Section F): 09/24/2024

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: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/29/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2024
• 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: 45 YR
• Patient Sex: Male