MAUDE Adverse Event Report: DENTSPLY VDW GMBH VDW GOLD/SILVER CONTRA ANGLE; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number V041079000000

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Contra-angle handpiece 2017 (101354) (cleaned and oiled).After thorough inspection and test measurements, we could not find any errors.

Event Description

In this event it was reported that a contra angle 6:1 for vdw.Gold/silver would not correctly rotate; no injury occurred.

Manufacturer Narrative

Please note, the incorrect manufacturer (g1) was inadvertently reported in the initial submission.See corrected manufacturer in (g1) of this report.

• Brand Name: VDW GOLD/SILVER CONTRA ANGLE
• 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: 9833034
• MDR Text Key: 190922340
• Report Number: 9611053-2020-00066
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V041079000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1