MAUDE Adverse Event Report: FKG DENTAIRE SARL ESRCM 40 .04 25MM; ENDODONTIC FILE

Model Number	ESRCM 40 .04 25MM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken device was discarded by the user and was therefore not available for evaluation.Manufacturing records have been reviewed and do not show any abnormality.To date, the information that have been collected and the outcome of the investigations of this case have not permitted to identify the root cause of this breakage.Since this endodontic instrument breakage results in left debris in the root canal, it has the potential to necessitate medical or surgical intervention.This malfunction is therefore reportable per 21 cfr part 803.
Event or Problem Description
While performing a root canal treatment, the endodontic file (esrcm 40.04 25mm) broke in the patient's mouth.The broken piece was left in the canal and no injury was reported.

• Brand Name: ESRCM 40 .04 25MM
• Common Device Name: ENDODONTIC FILE
• Manufacturer (Section D): FKG DENTAIRE SARL; le crêt-du-locle 4; le crêt-du-locle, 2322 ; SZ 2322
• Manufacturer (Section G): FKG DENTAIRE SARL; le crêt-du-locle 4; le crêt-du-locle, 2322 ; SZ 2322
• Manufacturer Contact: romain baize ; le crêt-du-locle 4; le crêt-du-locle, 2322 ; SZ 2322
• MDR Report Key: 21238942
• Report Number: 3006610063-2025-00001
• Device Sequence Number: 12874420
• Product Code: EKS
• UDI-Device Identifier: 00887919875680
• UDI-Public: (01)00887919875680(17)290801(10)LV23
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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: ESRCM 40 .04 25MM
• Device Catalogue Number: 5028089U0
• Device Lot Number: LV23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic