MAUDE Adverse Event Report: DENTSPLY VDW GMBH VDW CONNECT DRIVE CONTRA ANGLE 6:1; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number V041185000502

Device Problems Loss of Power (1475); Retraction Problem (1536)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.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 results are not available as of this report.Evaluation results will be submitted as they become available.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Event Description

In this event it was reported that a vdw.Connect drive handpiece suddenly stops.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Additional information was received indicating that no injury resulted.Pressure sensor is damaged.

• Brand Name: VDW CONNECT DRIVE CONTRA ANGLE 6:1
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• MDR Report Key: 9203509
• MDR Text Key: 169145139
• Report Number: 9611053-2019-00342
• Device Sequence Number: 1
• Product Code: EGS
• 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: 01/17/2020

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 Number: V041185000502
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2020
• Patient Sequence Number: 1