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

Catalog Number V041163000000

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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.Battery (was charged 118 times with an operating time of 14:38:11 hours, whereby 7 charging cycles would have been sufficient) defective.58881 foot control (cable break) defective.The housing has cracked in several places (probably due to a fall) has no effect on the function.Micromotor smr1212088 tested, without errors.Delivered without power supply.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 reciprocal motor stops during use; no injury resulted.

• 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: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 11061741
• MDR Text Key: 223409095
• Report Number: 9611053-2020-00159
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA#S-P#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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 05/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2020
• 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: Unknown
• Patient Sequence Number: 1