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 Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
In this event it is reported that a waveone gold small 3-file ster 31mm file broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Updated investigation results for this complaint: returned waveone gold small file 31mm is broken at the base of the active part (fatigue).No material defect was found during analysis of the rupture pattern.Nothing unusual to report was found during dhr review (batch #1911786).Root causes are not identified.We will track this kind of event and monitor the trend.
Additional Manufacturer Narrative
The investigation results for this complaint are: 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 #1911786).Root causes are not identified.We will track this kind of event and monitor the trend.Potential root causes may be incorrect technique, overuse, excessive wear, patient condition and behavior during treatment or material issue (no analysis of the broken fragments possible).In addition, there are further circumstances on the conditions in dentistry (used disinfectants, training/knowledge status), or any other environmental conditions, which are unknown to us and may also have an impact on the reported failure mode.
Additional Manufacturer Narrative
Additional information received that the broken part of the file could not be retrieved and patient has been referred to a endo specialist for removal of the file.This is a follow up report for this additional information.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code - 4582.Health effect - impact code - 4648.The correct codes for this complaint are: health effect - clinical code - 3165.Health effect - impact code - 2199.This is a follow up report to correct this code.
Additional Manufacturer Narrative
Additional information received: patient was sent to an endodontist the broken part has been removed & root canal completed.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code - 3165 the correct codes for this complaint are: health effect - clinical code - 4582 this is a follow up report to correct this code.

• 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: 24002727
• Report Number: 8031010-2026-00002
• Device Sequence Number: 13392475
• Product Code: EKS
• UDI-Device Identifier: D716WGSMALL311
• UDI-Public: D716WGSMALL311
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup,Followup
• Report Date (Section B): 03/06/2026

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/05/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/28/2026; 02/03/2026; 02/10/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown