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

Catalog Number V041153000000

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where stalling 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.Motor connection cable (loose contact) defective, battery (voltage breaks down under load) defective.Micromotor sm15291 (detected oil in motor) defective, contra angle 99927 (2016) and foot control 182612 do not indicate a defect.(st: 47; fi: 40; working hours: 58:22:30; enough is: 30).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.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

Event Description

In this event it was reported that a silver reciproc motor stops during use; no injury resulted.

• Brand Name: VDW SILVER RECIPROCATING MOTOR
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): VDW GMBH; bayerwaldstrasse 15; munich bayern, 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: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, pa ; 8494424
• MDR Report Key: 10431847
• MDR Text Key: 203699488
• Report Number: 9611053-2020-00125
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V041153000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1