MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL WAVEONE GOLD PRIMARY 3-FILE STER 21MM; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A0753221G0P03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	10/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that waveone gold primary 3-file ster 21mm file broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
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.
Additional Manufacturer Narrative
Additional information received that not all broken part have been retrieved from patient's mouth.No injury.Additional information after the above that further dental treatment given was rct of the affected tooth.This was completed with another set of files.Investigation results: summary: six waveone gold primary files 21mm were returned in loose.The six files are all broken at the tip of the active part (torque x5; fatigue + torque x1).No material defect was found during analysis of the rupture patterns.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1826255).Root causes are not identified.We will track this kind of event and monitor the trend.For information, we noted that one of the broken files has no red abs ring.Ring was voluntarily removed (tool marks are visible in the empty groove).We suspect the customer to have removed the abs ring to be able to reuse the file which would constitute a misuse.Indeed, waveone gold files are single use instruments whose abs ring is intended to prevent any reuse by expanding in case of sterilization of the instrument.

• Brand Name: WAVEONE GOLD PRIMARY 3-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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18181543
• Report Number: 8031010-2023-00875
• Device Sequence Number: 15366853
• Product Code: EKS
• UDI-Device Identifier: D716WGPRIME211
• UDI-Public: D716WGPRIME211
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/04/2024

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: A0753221G0P03
• Device Lot Number: 1826255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown