MAUDE Adverse Event Report: US ENDODONTICS, LLC. EDGETAPER; ENDODONTIC ROTARY FILE

Model Number	SETF225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The file fractured during an endodontic treatment (fracture occurred in the patient's mouth).The affected patient was not injured, and no medical care was required.The incident occurred 20 minutes after the start of the treatment.The dentist stated that the incident happened during the first use of the product and that they have experience using this product, as well as a similar product from rare euo.The practitioner stated that they did not sterilize the product before use.The cleaning protocol consisted of disinfection and lubrication.Regarding the sex of the affected patient, the dentist indicated both male and female.A request for clarification has been sent to determine if multiple patients were involved.The broken fragments could not be removed.The settings used were: power - 350 rpm, speed + 30 - 150, handpiece used fkg.The cannula was bent before injection.The files were discarded (no sample available for investigation).Quantity of parts impacted by the defect: 5.

• Brand Name: EDGETAPER
• Common Device Name: ENDODONTIC ROTARY FILE
• Manufacturer (Section D): US ENDODONTICS, LLC.; 2809 w walnut street; johnson city TN 37604
• Manufacturer (Section G): US ENDODONTICS, LLC.; 2809 w walnut street; johnson city TN 37604
• MDR Report Key: 22359738
• Report Number: 3008857765-2025-00001
• Device Sequence Number: 20832415
• Product Code: EKS
• UDI-Device Identifier: 00819514029892
• UDI-Public: 00819514029892
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/27/2025

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
• Operator of Device: Health Professional
• Device Model Number: SETF225
• Device Lot Number: 012522119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown