MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL WAVEONE GOLD GLIDER 015-02/25MM BLISTER 6; FILE, PULP CANAL, ENDODONTIC

Catalog Number	BSTW1GG625015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
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 results are not available 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 glider 015-02/25mm blister 6 file broke during use.The broken part has not been retrieved from patient's mouth.No injury occurred.
Additional Manufacturer Narrative
The investigation results for this complaint are: 23 unused waveone gold glider files 25mm were returned.Involved files that broke during use were not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1902901).The unused files returned were evaluated and were found in compliance with specifications.According to our prescriptions, we can consider that the production batch #1902901 is conforming (representative sample).No fault was found, production meets specifications.No fault found.Returned production meets specifications.

• Brand Name: WAVEONE GOLD GLIDER 015-02/25MM BLISTER 6
• 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
• MDR Report Key: 22795062
• Report Number: 8031010-2025-00143
• Device Sequence Number: 18221371
• Product Code: EKS
• UDI-Device Identifier: D716TSTW1GG3250151
• UDI-Public: D716TSTW1GG3250151
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: BSTW1GG625015
• Device Lot Number: 1902901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/12/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown