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

Model Number	PRECISION TORQUE 2CR SS
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor states that the handpices does not hold the burs she is using to treat patient.She is unable to push them in, therefore, when she treats patients the burs fall out.

• Brand Name: HENRY SCHEIN
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 3f, no. 7, 6th road; industry park, taichung 40755 ; TW 40755
• MDR Report Key: 20378505
• Report Number: 3007007357-2024-00029
• Device Sequence Number: 17857424
• Product Code: EFB
• UDI-Device Identifier: 00304040064375
• UDI-Public: (01)00304040064375
• 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 B): 10/04/2024
• Report Date (Section F): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRECISION TORQUE 2CR SS
• Device Catalogue Number: 570-0741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/05/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/04/2024