MAUDE Adverse Event Report: DENTSPLY VDW GMBH VDW CONNECT DRIVE; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number V041183000000

Device Problems Break (1069); Incorrect Measurement (1383); Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona.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 Description

In this event it was reported that a vdw.Connect drive motor in combination with a vdw.Connect locate gave incorrect measurements; no injury occured.The dentist noticed that the measurement socket of the motor is broken.

Manufacturer Narrative

Handpiece 07493 (measurement socket broken, probably due to fall down) defect, replaced with 09460.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

• Brand Name: VDW CONNECT DRIVE
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• MDR Report Key: 9566447
• MDR Text Key: 190616422
• Report Number: 9611053-2019-00471
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V041183000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/09/2020
• Patient Sequence Number: 1