MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL WAVEONE GOLD PRIMARY 6-FILE STER 31MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A0756231G0P03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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 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 a waveone gold primary 6-file ster 31mm file broke during use.The broken part has not been retrieved and appointment is scheduled for further removal/treatment.No injury reported.Further information requested.
Additional Manufacturer Narrative
Additional information received: the broken part has been retrieved after many attempts.Medical care will continue - endodontic treatment.This is a follow up report for this additional information.Investigation results returned waveone gold primary file 31mm is broken in the active part (fatigue).No material defect was found during analysis of the rupture pattern.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1838631).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 - clinical code - 3165 the correct codes for this complaint are: health effect - clinical code - 4582 this is a follow up report to correct this code.

• Brand Name: WAVEONE GOLD PRIMARY 6-FILE STER 31MM
• 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: 22770365
• Report Number: 8031010-2025-00139
• Device Sequence Number: 21112266
• Product Code: EKS
• UDI-Device Identifier: D716WGPRIME311
• UDI-Public: D716WGPRIME311
• 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): 09/04/2025

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: A0756231G0P03
• Device Lot Number: 1838631
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown