MAUDE Adverse Event Report: TTBIO CORP. HENRY SCHEIN; ULTRASONIC SCALER

Model Number	ACCLEAN ULTRASONIC SCALER
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scaler was not returned for evaluation and the serial number or batch number was unknown, no information is available for troubleshooting.Besides, the tip (acclean ergo x-thin universal) used in this event is not manufactured by ttbio.
Event or Problem Description
This vmsr report summarizes one malfunction event.The customer stated they were performing perio maintenance on the 69-year-old male patient with this scaler product (b)(4) when the bur, the acclean ergo x-thin universal, item code # 112-6734, broke while they were removing calculus.They were able to retrieve the broken piece(s).There was no patient injury.The speed was not able to be provided.They normally disinfect/ sterilize the acclean instrument by wiping with cavicide then running it through their autoclave.This is the first time this happened.

• Brand Name: HENRY SCHEIN
• Common Device Name: ULTRASONIC SCALER
• Manufacturer (Section D): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer (Section G): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer Contact: jun li ; 2f., no.7, 6th road; industry park; taichung, 40755
• MDR Report Key: 21188245
• Report Number: 3010364969-2025-00005
• Device Sequence Number: 12946659
• Product Code: ELC
• UDI-Device Identifier: 00304040155837
• UDI-Public: (01)00304040155837
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201317
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

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: ACCLEAN ULTRASONIC SCALER
• Device Catalogue Number: 570-2771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 01/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male