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	03/03/2025
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 could not be retrieved and was incorporated into the filling.No injury.
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
Summary: involved product 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 #1878926).Customer stated having used the file 9 times before that the breakage occurs.Waveone gold files are single use instruments which must not be reused.Reuse of the instrument constitutes a misuse from the customer.Additionally, dfu indicates that waveone gold instruments should not be used in cases of severe and sudden apical curvatures.Root cause is customer misuse.

• 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: 21919197
• Report Number: 8031010-2025-00064
• Device Sequence Number: 15708896
• 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,Followup
• Report Date (Section B): 06/13/2025

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: 1878926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown