MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER ULTIMATE F2 25MM X6; FILE, PULP CANAL, ENDODONTIC

Catalog Number	BSTPULR6250F2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no injury was reported, 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 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event, it is reported that a protaper ultimate f2 25mm x6 file broke during use.The outcome of this event is unknown as of this mdr.No injury.Further information requested.
Additional Manufacturer Narrative
No further information has been received after 3 documented attempts.Moreover, the investigation results for this complaint are: four unused protaper ultimate files f2 25mm were returned.Involved instrument that broke during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1909881).The unused files returned were evaluated, but the number of unused instruments received is not enough to determine if the batch is in compliance with specifications regarding our prescriptions.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: PROTAPER ULTIMATE F2 25MM X6
• 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: 22725529
• Report Number: 8031010-2025-00134
• Device Sequence Number: 13047406
• Product Code: EKS
• UDI-Device Identifier: D716PTGRF2251
• UDI-Public: D716PTGRF2251
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/11/2025

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: BSTPULR6250F2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/30/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown