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

Catalog Number	A0756221G0L03
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
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 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 large 6-file ster 21mm broke during use.The broken part could not be retrieved.Patient referred to endo specialist for removal of broken part.No injury.
Additional Manufacturer Narrative
Additional information received that the fragment has been removed and the treatment completed.This is a follow up report for this additional information.Investigation: three waveone gold primary files 25mm were returned (two files in loose + one unused file).First file in loose is broken at the tip of the active part (fatigue).No material defect was found during analysis of the rupture pattern.Second file has no damage and seems unused.Nothing unusual to report was found during dhr review (batch #1851184).Unused file was evaluated and was found in compliance with specifications.Root causes are not identified.We will track this kind of event and monitor the trend.Root causes are not identified.

• Brand Name: WAVEONE GOLD LARGE 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: 20577540
• Report Number: 8031010-2024-00135
• Device Sequence Number: 8827605
• Product Code: EKS
• UDI-Device Identifier: D716WGLARGE211
• UDI-Public: D716WGLARGE211
• 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): 11/26/2024

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: A0756221G0L03
• Device Lot Number: 1851184
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/28/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown