MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER GOLD S1 25MM STER; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A0410225G0103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that protaper gold s1 25mm ster broke during use.The broken parts still remain in the root canal.Patient(s) referred to an endo specialist to remove broken parts.Further information requested for the outcome on pending treatment.
Additional Manufacturer Narrative
Additional information received: the outcomes for the patients with the broken files, a fragment had to remain in situ and the tooth was sealed with a root filling.As for the other fragment, we still don't know whether it could be removed.Investigation summary: nine protaper gold shaping files s1 25mm were returned (1 file in loose + 8 unused files).The file in loose is broken at the tip of the active part (torque).No material defect was found during analysis of the rupture pattern.Nothing unusual to report was found during dhr review.Unused files were evaluated and were found in compliance with specifications.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: PROTAPER GOLD S1 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18562594
• Report Number: 8031010-2024-00003
• Device Sequence Number: 8034025
• Product Code: EKS
• UDI-Device Identifier: D716PTGRS1251
• UDI-Public: D716PTGRS1251
• 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): 02/20/2024

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: A0410225G0103
• Device Lot Number: 1825674
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/12/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown