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 Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.An apicoectomy was performed to remove the broken part.
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: involved waveone gold small file 25mm that broke during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1854536).No unused file batch #1854536 is available for evaluation.Root causes are not identified.We will track this kind of event and monitor the trend.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• 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: 21207732
• Report Number: 8031010-2025-00007
• Device Sequence Number: 8071309
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2025

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?: No
• Distributor Facility Aware Date: 01/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown