MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL WAVEONE GOLD PRIMARY 3-FILE STER 25MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A0753225G0P03
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 waveone gold primary 3-file ster 25mm file broke during use.The broken parts remain in patient's tooth.No injury occurred.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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Investigation results: summary: involved waveone gold primary file 25mm that broke during use was not returned physically and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #(b)(4)).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique, overuse, excessive wear, patient condition and behavior during treatment or material issue (no analysis of the broken fragments possible).In addition, there are further circumstances on the conditions in dentistry (used disinfectants, training/knowledge status), or any other environmental conditions, which are unknown to us and may also have an impact on the reported failure mode.Additional information received: the patient did not suffer any injury.The broken parts were removed from the patient's mouth.The instrument was used for the first time and broke, so another instrument was used and also broke on first use.No medical or surgical treatment was necessary after the event.Treatment was not completed.
Additional Manufacturer Narrative
The investigation results for this complaint are: eight waveone gold primary files 25mm were returned (two files in loose and six unused files).The files in loose are both broken in the active part (torque; fatigue).Second file in loose has no more abs ring.Ring was voluntarily removed to allow the reuse of the instrument (breakage occurred during the reuse according to the customer alignment).No material defect was found during analysis of the rupture patterns.Nothing unusual to report was found during dhr review (batch #1897070).The six unused files were evaluated and were found in compliance with specifications.¿root causes are not identified regarding first broken file.We will track this kind of event and monitor the trend.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.Root cause is customer misuse regarding second broken file.Indeed, waveone gold files are single use sterile items which must not be sterilized and reused.Correcting code - removing previously reported type of investigation code 4114.This is a follow up report for this corrected information.

• Brand Name: WAVEONE GOLD PRIMARY 3-FILE STER 25MM
• 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: 23096147
• Report Number: 8031010-2025-00157
• Device Sequence Number: 9347285
• Product Code: EKS
• UDI-Device Identifier: D716WGPRIME251
• UDI-Public: D716WGPRIME251
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 11/03/2025

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: A0753225G0P03
• Device Lot Number: 1897070
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/09/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 09/23/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown