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 Problems Insufficient Information (4580); 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.Contra-angle handpiece 2060 (no apex function, head part is depressed) defective, battery (which breaks down under load) defective, the housing has broken a several place (possibly due to impact) has no function.Micromotor (b)(4) and foot control (b)(4) read without errors.

Event Description

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

Manufacturer Narrative

Contra-angle 2060 (2016) (no apex function, head part is depressed) defective, battery (voltage breaks down under load) defective, the housing is on broken into several places (presumably due to a collision) has no effect on the function.Micromotor smr113118 and foot control 100502 tested without errors.Delivered without power supply.

• 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
• MDR Report Key: 10519137
• MDR Text Key: 208584316
• Report Number: 9611053-2020-00236
• Device Sequence Number: 1
• Product Code: EBW
• 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: 10/08/2021

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: 08/07/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1