MAUDE Adverse Event Report: VDW GMBH MACHTOU-PLUGGER 001/002; PLUGGER, ROOT CANAL, ENDODONTIC

Catalog Number V041063001002

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

In this event it is reported that machtou-plugger 001/002 broke during use.The outcome of this event is unknown as of this mdr; further information requested.

Manufacturer Narrative

There has been a previous report received with a similar device 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.This event will be re-evaluated, as appropriate, if additional information becomes available.The involved machtou plugger 001/002 that broke during use was not returned. through the sent pictures, we can see that the two active parts of the plugger are broken at the base, at the last depth mark level.No further analysis can be performed.Nothing unusual to report was found during dhr review (batch #1795895).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: MACHTOU-PLUGGER 001/002
• Type of Device: PLUGGER, ROOT CANAL, ENDODONTIC
• Manufacturer (Section D): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer (Section G): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16911514
• MDR Text Key: 315003987
• Report Number: 9611053-2023-00783
• Device Sequence Number: 1
• Product Code: EKR
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V041063001002
• Device Lot Number: 1795895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/02/2023
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1