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

Catalog Number V041063001002

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Since there has been a previous report received with the same product where this malfunction resulted in a serious injury 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.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 machtou plugger separated; the broken piece has been retrieved.No injury resulted.

Manufacturer Narrative

The active part #1 of the returned plugger is actually broken in the middle depth ring.No material defect was found during analysis of the rupture pattern.Active part #2 is not damaged.Nothing unusual to report was found during dhr review.Root causes are not identified.We will track this kind of event and monitor the trend.For information, msa recommends to do not apply a too high bending force during the use of this instrument.

• Brand Name: MACHTOU PLUGGER 001/002
• Type of Device: PLUGGER, ROOT CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7151150
• MDR Text Key: 96128657
• Report Number: 9611053-2017-00094
• Device Sequence Number: 1
• Product Code: EKR
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V041063001002
• Device Lot Number: 8433910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1