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

Catalog Number	A0756225G0S03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a waveone gold small 6-file ster 25mm file broke during use.The outcome of this event is unknown as of this mdr.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 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 summary: seven waveone gold small files 25mm were returned (one file in loose + six unused files).File in loose is broken in the active part (mixed conditions torque + fatigue).No material defect was found during analysis of the rupture pattern.Nothing unusual to report was found during dhr review (batch#: 1860653).Unused files were evaluated and were found in compliance with specifications.Root causes are not identified.We will track this kind of event and monitor the trend.Additional information received: the patient decided against an apicoectomy and wanted to leave the file fragment in the root canal after detailed explanation.The tooth was then filled with ah-plus and gutta-percha.This is a follow up report for this additional information.Correcting lot# from 1860653 to 1854536.This is a follow up report for this corrected information.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code - 4580.Health effect - impact code - 4648.The correct codes for this complaint are: health effect - clinical code - 4582.Health effect - impact code - 2199.This is a follow up report to correct this code.

• Brand Name: WAVEONE GOLD SMALL 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: 20903885
• Report Number: 8031010-2024-00165
• Device Sequence Number: 8948745
• Product Code: EKS
• UDI-Device Identifier: D716WGSMALL251
• UDI-Public: D716WGSMALL251
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/13/2025

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: A0756225G0S03
• Device Lot Number: 1854536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown