MAUDE Adverse Event Report: DENTSPLY VDW GMBH WST 6:1 F. VDW GOLD/SILVER; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number V041079000000

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.Contra angle 6:1 (bearing defect at the head), defect.Device was scrapped.

Event Description

In this event it was reported that a contra angle 6:1 for vdw.Gold/silver was involved to a file breakage; no injury resulted.

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: WST 6:1 F. VDW GOLD/SILVER
• 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: 7940276
• MDR Text Key: 123806521
• Report Number: 9611053-2018-00150
• 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: 10/05/2018
• 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: 09/07/2018
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1