MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL WAVEONE GOLD PRIMARY 6-FILE STER 25MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A0756225G0P03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a waveone gold primary 6-file ster 25mm file broke during use.Reportedly, broken part was retrieved but no information was received about any patient injury.Further information requested.
Additional Manufacturer Narrative
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 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: we received the following information regarding this complaint: has any patient been injured? no.Has any further medical or surgical treatment been necessary after the event? yes, the broken part of the root canal has been removed.Please return the material for investigation.The broken file has been discarded.This is a follow report for this additional information.The investigation results for this complaint are: involved waveone gold primary file 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 #1860947).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.

• Brand Name: WAVEONE GOLD PRIMARY 6-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: 22704763
• Report Number: 8031010-2025-00131
• Device Sequence Number: 9036071
• Product Code: EKS
• UDI-Device Identifier: D716WGPRIME251
• UDI-Public: D716WGPRIME251
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: A0756225G0P03
• Device Lot Number: 1860947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown