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 Detachment of Device or Device Component (2907); Mechanics Altered (2984)

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

Event Type  malfunction  

Event Description

In this event it is reported that vdw gold/silver won't hold files.No injury occurred.

Manufacturer Narrative

There has been a previous report received with a similar device 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.

Manufacturer Narrative

Investigation found: nc073292/ca-sn:(b)(6):micromotor gmr2086025 and contra angle 143217 (2020) can no longer be separated.(if the cleaning process is not checked for years, then the assembly will corrode, or after an impact, in this case, the micromotor will bend and can no longer be separated).Therefore, please check your care and cleaning process.Replaced with gmr2297029 and with contra angle sn:(b)(6).Function test without error.Customer misuse/abuse.Contra angle and motor corroded due to less maintenance.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: 15360341
• MDR Text Key: 305696874
• Report Number: 9611053-2022-00622
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/18/2022

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 Catalogue Number: V041079000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/02/2022
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1