MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL WAVEONE GOLD PRIMARY 6-FILE STER 21MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A0756221G0P03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a waveone gold primary 6-file ster 21mm file broke during use.The broken part has not yet been retrieved as of this mdr.Retrieval of the broken part is planned.No injury occurred.
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.Investigation results: involved file that broke during use was not returned and cannot be analyzed.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1891157).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.Root causes are not identified.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• Brand Name: WAVEONE GOLD PRIMARY 6-FILE STER 21MM
• 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: 22636899
• Report Number: 8031010-2025-00125
• Device Sequence Number: 18181396
• Product Code: EKS
• UDI-Device Identifier: D716WGPRIME211
• UDI-Public: D716WGPRIME211
• 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
• Report Date (Section B): 07/28/2025

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: A0756221G0P03
• Device Lot Number: 1891157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/18/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown