MAUDE Adverse Event Report: SS WHITE BURS LLC EXACT TAPER; FILE, PULP CANAL, ENDODONTIC

Model Number	UTTHF325
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device was not returned for investiagtion due to the file remaining in the patients tooth.However, an investigation was performed using a different lot number and the results of the 12-piece sample showed to be above specifications.
Event or Problem Description
During a dental procedure on (b)(6) 2025, an endodontic file broke on initial insertion of file.The file broke off above the cutting flute which resulted in the file remaining in the patients tooth.Ss white burs was made aware of this incident on (b)(6) 2025.

• Brand Name: EXACT TAPER
• Common Device Name: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): SS WHITE BURS LLC; 1145 towbin ave; lakewood 08701
• Manufacturer (Section G): SS WHITE BURS LLC; 1145 towbin ave; lakewood 08701
• Manufacturer Contact: mariam sawaqed ; 1145 towbin ave; lakewood 08701
• MDR Report Key: 23025753
• Report Number: 2245654-2025-00013
• Device Sequence Number: 18520278
• Product Code: EKS
• UDI-Device Identifier: D690TTHF3252
• UDI-Public: D690TTHF3252
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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
• Device Model Number: UTTHF325
• Device Catalogue Number: TTHF325
• Device Lot Number: L04F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 17 YR
• Patient Sex: Male