MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER H-U 25MM/F2 *NOT CE*; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A041702510212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a protaper h-u 25mm/f2 not ce file broke during use.The broken part has not been retrieved and has been referred to specialist for further treatment.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Additional information has been received that the broken part has been removed from the patient's mouth without further medical or surgical treatment.No injury.This is a follow up report for this additional information.The investigation results for this complaint are returned protaper h-u finishing file f2 25mm is broken in the active part (fatigue).No material defect was found during analysis of the rupture pattern.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1761303).Root causes are not identified.We will track this kind of event and monitor the trend.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code - 3165 health effect - impact code - 4648 the correct codes for this complaint are: health effect - clinical code - 4582 health effect - impact code - 2199 this is a follow up report to correct this code.

• Common Device Name: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22770638
• Report Number: 8031010-2025-00140
• Device Sequence Number: 15788334
• Product Code: EKS
• UDI-Device Identifier: D716PTUHF2251
• UDI-Public: D716PTUHF2251
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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
• Device Catalogue Number: A041702510212
• Device Lot Number: 1761303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown