MAUDE Adverse Event Report: TTBIO CORP HENRY SCHEIN; HANDPIECE

Model Number	PRO 2-N SLIDE LATCH HEAD
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Head part of device fell apart into patient's mouth during removal of decay.

• 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: 17613385
• Report Number: 3007007357-2023-00009
• Device Sequence Number: 18020222
• Product Code: EFB
• UDI-Device Identifier: 00304040126424
• UDI-Public: 0100304040126424
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/24/2023
• Report Date (Section F): 08/24/2023

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: PRO 2-N SLIDE LATCH HEAD
• Device Catalogue Number: 570-1766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/27/2023
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2023
• 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 Sex: Male
• Date Report Sent to FDA: 08/24/2023