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

Catalog Number	V041441000000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.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.
Event or Problem Description
In this event it is reported that eddy irrigation tips broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Investigation results: no product was made available for investigation following two documented attempts for such.Dhr without fault.No further investigation.Root cause cannot be determined.No issues were detected during production of claimed lot.Production vdw batch # 464110 meets specifications.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
Additional Manufacturer Narrative
The complaint investigation was reopened, as against previous information a product (one eddy tip) has been made available for investigation without further notice.Visual inspection: we received one eddy tip broken in two pieces.The eddy tip is broken at the tip.Measurement: broken part is available and measuring approx.4,82 mm, remaining active part measuring approx.23,18 mm.Total of active part is complete, measuring 28 mm (measured with measuring gauge mitutoyo pm# 1749 valid till 5/2026).No part of the eddy tip is missing.Injection tool cavity is #2.The active part is melted at the tip (broken tip due to thermal effect).No unused product was received for investigation.Dhr review for the claimed lot 464110 was performed (no dhr issue was detected.The final root cause cannot be determined.Correlation between adverse event and the involved medical devices.The important information of adverse event is incomplete or unavailable, and the cause of adverse events of medical devices cannot be determined.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• Brand Name: EDDY
• Common Device Name: 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22195938
• Report Number: 9611053-2025-00088
• Device Sequence Number: 8837593
• Product Code: EIC
• UDI-Device Identifier: 07640159160090
• UDI-Public: 07640159160090
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2025

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: V041441000000
• Device Lot Number: 464110
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/19/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 09/22/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown