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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY VDW GMBH RECIPROC FILES 6X; FILE, PULP CANAL, ENDODONTIC

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DENTSPLY VDW GMBH RECIPROC FILES 6X; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number V040212025025
Device Problem Break (1069)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
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.
 
Event Description
In this event it was reported that a reciproc file broke during use.The separated piece could not be retrieved and was incorporated into the filling.
 
Manufacturer Narrative
Three reciproc files r25 8/100 25mm 025 were returned (one file in loose + two unused files).The file in loose is actually broken at the tip of the active part (fatigue).No material defect was found during analysis of the rupture pattern.For information, the second file which would have broken during use was not returned and cannot be analyzed.The batch number is unknown, dhr cannot be reviewed.Unused files have been evaluated and were found in compliance with specifications.Root causes are not identified.We will track this kind of event and monitor the trend.
 
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Brand Name
RECIPROC FILES 6X
Type of Device
FILE, PULP CANAL, ENDODONTIC
Manufacturer (Section D)
DENTSPLY VDW GMBH
bayerwaldstrasse 15
munich, 81737
GM  81737
Manufacturer (Section G)
DENTSPLY VDW GMBH
bayerwaldstrasse 15
munich, 81737
GM   81737
Manufacturer Contact
hannah seevaratnam
221 w. philadelphia st.
york, PA 17401
7178494593
MDR Report Key12597767
MDR Text Key276853144
Report Number9611053-2021-00320
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 11/16/2021
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 Operator Health Professional
Device Catalogue NumberV040212025025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/09/2021
Initial Date FDA Received10/08/2021
Supplement Dates Manufacturer Received09/09/2021
Supplement Dates FDA Received11/16/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Patient Sequence Number1
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