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

Catalog Number V041441000000

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that 2 eddy tips possibly broke during use.The outcome of this event is unknown as of this mdr.Further information requested.

Manufacturer Narrative

Investigation: nothing unusual to report was found during dhr review.Investigation done: no smooth breakge, breakage do to thermal influeance.Misuse since customer used lenght mark and activated outside the tooth.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.Root cause: customer misuse/abuse conclusion code: abnormal use.Additional information: additional information received that tips broke in the root canal but could be removed.No follow up treatment necessary.

• 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: 17412614
• MDR Text Key: 320292520
• Report Number: 9611053-2023-00825
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V041441000000
• Device Lot Number: 406549
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/25/2023
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1