MAUDE Adverse Event Report: TTBIO CORPORATION MASTER 3; HANDPIECE

Model Number MASTER 3 STANDARD PB

Device Problem Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/08/2021

Event Type  Injury  

Event Description

The doctor was performing a procedure on the patient and the multi-fluted carbide bur came out of the highspeed and the patient swallowed it.The patient swallowed bur and the mcd wants him to go the er immediately.The patient sought treatment at the (b)(6).Although the dental office attempted to contact the patient, they were unable to reach them.The patient has not received any further treatment at the dental office.

Manufacturer Narrative

Root cause: root cause cannot be fully determined although it can be confirmed that the chuck failed product specifications.

• Brand Name: MASTER 3
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORPORATION; 2f., no.07; 6th industry park; taichung, 40755 ; TW 40755
• MDR Report Key: 13067758
• MDR Text Key: 282736579
• Report Number: 3010364969-2021-00002
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MASTER 3 STANDARD PB
• Device Catalogue Number: 570-0486
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male