MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL VERIFIER 25MM 020; FILE, PULP CANAL, ENDODONTIC

Catalog Number	A017502502000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
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.
Event or Problem Description
In this event it is reported that verifier 25mm 020 file broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Summary: involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.The provided batch number #7079060 shows that this production was made on 2010.Dhr is not available anymore, review cannot be performed.Root causes are not identified.We will track this kind of event and monitor the trend.
Additional Manufacturer Narrative
Additional information received: deviced received.Investigation results: five verifiers 25mm 020 were returned (one file in loose + four unused files).File in loose is broken at the base of the active part (fatigue).No material defect was found during analysis of the rupture pattern.The batch number #7079060 shows that this production was made on 2010.Dhr is not available anymore, review cannot be performed.Unused files were evaluated and were found in compliance with specifications.Root causes are not identified.We will track this kind of event and monitor the trend.Correcting previously submitted codes: type of investigation removing 4114 and adding 10.Investigation findings removing 3221 and adding 213.This is a follow up report for these corrected/updated codes.

• Brand Name: VERIFIER 25MM 020
• 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: 18358208
• Report Number: 8031010-2023-00884
• Device Sequence Number: 17748955
• Product Code: EKS
• UDI-Device Identifier: D716SVK6201
• UDI-Public: D716SVK6201
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• 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
• Report Date (Section B): 02/09/2024

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: A017502502000
• Device Lot Number: 7079060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/06/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 12/06/2023; 12/06/2023
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/19/2024; 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown