MAUDE Adverse Event Report: TTBIO CORP HENRY SCHEIN; HANDPIECE

Model Number MAXIMA PRO 2L AR

Device Problems Accessory Incompatible (1004); Component Incompatible (1108)

Patient Problem Laceration(s) (1946)

Event Date 03/05/2024

Event Type  Injury  

Event Description

Bur used in handpiece bent while in use and injured patient.

• Brand Name: HENRY SCHEIN
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 19020124
• MDR Text Key: 339117816
• Report Number: 3007007357-2024-00010
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00304040133682
• UDI-Public: (01)00304040133682
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/02/2024,04/01/2024

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
• Device Operator: Health Professional
• Device Model Number: MAXIMA PRO 2L AR
• Device Catalogue Number: 570-2094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2024
• Distributor Facility Aware Date: 03/07/2024
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/05/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female