MAUDE Adverse Event Report: TTBIO CORP. MAXIMA PRO 2; HANDPIECE

Model Number MAXIMA PRO 2

Device Problems Accessory Incompatible (1004); Component Incompatible (1108); Misassembly by Users (3133)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2022

Event Type  malfunction  

Event Description

Assistant stated that they had two separate handpieces that caused the doctor issues.One handpiece a komet 557 bur which they buy directly from komet, came out of the handpiece during a surgical extraction procedure with an 83 year old male patient.The bur was removed and there was no patient harm or medical attention required.As for the second handpiece while it was being used it was leaking out of the back button cap of it.This was while with a 56 year old male patient.Again no patient harm or medical attention required.Unfortunately, they do not remember which handpiece was used with which patient.

• Brand Name: MAXIMA PRO 2
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 2f, no.7, 6th road industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 15260852
• MDR Text Key: 298284426
• Report Number: 3007007357-2022-00009
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/22/2022,08/19/2022

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
• Device Operator: Health Professional
• Device Model Number: MAXIMA PRO 2
• Device Catalogue Number: 570-1072
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2022
• Distributor Facility Aware Date: 07/22/2022
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male