MAUDE Adverse Event Report: VDW GMBH EDDY; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Model Number 21419

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

In this event it is reported that eddy irrigation tips broke during use.All broken parts were retrieved and no further treatments were needed.No injury occurred.

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, 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: dhr check done.Nothing unusual to report was found during dhr check.According to manufacturing center 1 customer misuse.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• Brand Name: EDDY
• Type of Device: SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
• 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: 17298364
• MDR Text Key: 319314939
• Report Number: 9611053-2023-00817
• Device Sequence Number: 1
• Product Code: EIC
• UDI-Device Identifier: 07640159160090
• UDI-Public: 07640159160090
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21419
• Device Catalogue Number: V041441000000
• Device Lot Number: 417905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/10/2023
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1