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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY VDW GMBH MTWO NITI FILE 25MM, 15/.05, 21MM WORKING PART, STERILE; FILE, PULP CANAL, ENDODONTIC
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DENTSPLY VDW GMBH MTWO NITI FILE 25MM, 15/.05, 21MM WORKING PART, STERILE; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number V041235025015
Device Problem Break (1069)
Patient Problems Apicectomy (2372); No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Therefore, because medical intervention is required, this event is reportable per 21 cfr 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.
 
Event Description
In this event it was reported that a mtwo file broke during use; apicoectomy may be necessary.
 
Manufacturer Narrative
The involved mtwo unifile 5/100 ad25 015 is actually broken at the tip of the active part (fatigue).No material defect was found during analysis of the rupture pattern.Unused product has been evaluated according to our prescriptions and was found in compliance with specifications (measures, torque test).Nothing unusual to report was found during dhrs review (batches #1523614, 1520097).Root causes are not identified.This kind of event is tracked and we monitor the trend.
 
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Brand Name
MTWO NITI FILE 25MM, 15/.05, 21MM WORKING PART, STERILE
Type of Device
FILE, PULP CANAL, ENDODONTIC
Manufacturer (Section D)
DENTSPLY VDW GMBH
bayerwaldstrasse 15
munich, 81737
GM  81737
MDR Report Key8760544
MDR Text Key150167513
Report Number9611053-2019-00192
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV041235025015
Device Lot Number261922
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Date Manufacturer Received08/30/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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