MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER GOLD ASSORT SX/F3 31MM STER; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A0409231G0103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a protaper gold assort sx/f3 31mm ster file broke during use.The broken part has not been retrieved from patient's root canal.Outcome is unknown as of this mdr as treatment is still undergoing.Further information requested.
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.
Additional Manufacturer Narrative
Additional information received - the endodontic treatment stage has been completed.The root canal has been filled with the broken part of the instrument left inside.This is a follow up for this additional information.Investigation results: summary: six assorted protaper gold files 19 and 31mm (sx-f3) were returned in loose.After analysis, we can see that the ptg s1 31mm is untwisted at the tip of the active part (torque) and that the ptg s2 31mm is broken at the base of the active part (fatigue).No material defect was found during analysis of the damaged area or the rupture pattern.The other returned files are not damaged.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1897297).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 - impact code - 4648.The correct codes for this complaint are: health effect - impact code - 2199.This is a follow up report to correct this code.

• Brand Name: PROTAPER GOLD ASSORT SX/F3 31MM 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: 23014020
• Report Number: 8031010-2025-00153
• Device Sequence Number: 13155168
• Product Code: EKS
• UDI-Device Identifier: D716PTGRA311
• UDI-Public: D716PTGRA311
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 09/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A0409231G0103
• Device Lot Number: 1897297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/28/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown