MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER GOLD F2 25MM STER; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A0411225G0203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Investigation results: involved files that broke during use were not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1801287).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique, overuse (number of uses not communicated), excessive wear, patient condition and behavior during treatment or material issue (no analysis of the broken fragments possible).In addition, there are further circumstances on the conditions in dentistry (used disinfectants, training/knowledge status), or any other environmental conditions, which are unknown to us and may also have an impact on the reported failure mode.Root causes are not identified.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
Event or Problem Description
In this event it is reported that a protaper gold f2 25mm ster file broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Additional information received that there was no injury that occurred for this event.This is a follow up report for this additional information.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code - 4580 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.
Additional Manufacturer Narrative
The investigation results for this complaint are: involved files that broke during use were not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1801287).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique, overuse (number of uses not communicated), excessive wear, patient condition and behavior during treatment or material issue (no analysis of the broken fragments possible).In addition, there are further circumstances on the conditions in dentistry (used disinfectants, training/knowledge status), or any other environmental conditions, which are unknown to us and may also have an impact on the reported failure mode.
Additional Manufacturer Narrative
Additional information received that the broken parts have been left in the patient's mouth.No injury.This is a follow up report for this additional information.

• Brand Name: PROTAPER GOLD F2 25MM STER
• 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: 22697812
• Report Number: 8031010-2025-00129
• Device Sequence Number: 8986477
• Product Code: EKS
• UDI-Device Identifier: D716PTGRF2251
• UDI-Public: D716PTGRF2251
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A0411225G0203
• Device Lot Number: 1801287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/28/2025; 09/04/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown