MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL WAVEONE GOLD SMALL 3-FILE STER 31MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A0753231G0S03
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 has not been returned as of this report.Evaluation results will be submitted as they become available.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.
Event or Problem Description
In this event it is reported that waveone gold small 3-file ster 31mm broke during use.The broken part could not be retrieved and patient was referred to endo specialist.
Additional Manufacturer Narrative
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 #1659896).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique (motor setting not communicated), overuse (like it may be the case here - file used 12 times while the instrument is a non-reusable / single use item), excessive wear, or material issue (no analysis of the broken fragments possible).Root causes are not identified.

• Brand Name: WAVEONE GOLD SMALL 3-FILE STER 31MM
• 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: 20462905
• Report Number: 8031010-2024-00120
• Device Sequence Number: 12732659
• Product Code: EKS
• UDI-Device Identifier: D716WGSMALL311
• UDI-Public: D716WGSMALL311
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: A0753231G0S03
• Device Lot Number: 1659896
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown