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 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 gold s1 25mm ster file broke during use.The broken part located in the canal of #26 could not be retrieved.A root-end resection may be necessary for tooth 26.The patient was not injured.
Additional Manufacturer Narrative
The investigation results for this complaint are: involved protaper gold shaping file s1 25mm that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1897289).In his declaration, the practitioner stated having prepared the glide path by using only a k-file size 010 before to use the protaper gold shaping file s1 25mm.Per ifu, we recommend to prepare the glide path with k-files size 010 and 015 at once.We can consider that there was a customer misuse on that point.We invite the customer to step 5 + 6 of the step-by-step instructions to reach a workflow with reduced file stress and smooth transitions between files.Root cause is customer misuse.

• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22413811
• Report Number: 8031010-2025-00108
• Device Sequence Number: 15876172
• 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): 07/16/2025

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: A0410225G0103
• Device Lot Number: 1897289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/24/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown