MAUDE Adverse Event Report: DENTSPLY VDW GMBH VDW SILVER RECIPROCATING MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number V041163000000

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 when taking into account composition and indications for use.Evaluation found a damaged bearing and a battery defect.

Event Description

In this event it was reported that a vdw.Silver motor potentially caused a file to break.No injury occurred.

• Brand Name: VDW SILVER RECIPROCATING MOTOR
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer (Section G): ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.; via san donato 1; pistoia, 51100 ; IT 51100
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7180177
• MDR Text Key: 96957818
• Report Number: 9611053-2017-00100
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/10/2018

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: V041163000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1