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

Catalog Number V041079000000

Device Problems Mechanical Problem (1384); Unexpected Shutdown (4019)

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

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that wst 6:1 f.Vdw.Gold/silver stops during treatment.No injury occurred.

Manufacturer Narrative

Investigation results: nc074934/ca-(b)(6)/gr18616:battery (breaks down under load) defective, replaced.Contra angle 82350 (2015) (worn head drive) defective, repaired.Foot switch 110231 (loose contact) defective, replaced with 214830.The housing has broken in several places (probably due to a fall), but has no effect on the function.The charger, the motor gmr1553638, the motor cable and the measuring cable set after a thorough check, no fault could be found.Function test and test measurements without errors.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• Brand Name: WST 6:1 F. VDW.GOLD/SILVER
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer (Section G): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16263000
• MDR Text Key: 309138062
• Report Number: 9611053-2023-00724
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V041079000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/26/2023
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1