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

Catalog Number	V041441000000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional 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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Event or Problem Description
In this event it is reported that eddy irrigation tip broke during use.No injury occurred.
Additional Manufacturer Narrative
No issues were detected during production of claimed lot.Production vdw batch # 429738 meets specifications.No further investigation since product was confirmed to have been discarded.Dhr without fault.Root cause cannot be determined.We were updated that the broken part could be removed and the involved product had been discarded.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.Potential root causes may be incorrect technique, overuse (number of uses not communicated), excessive use, patients condition and behavior during treatment or material issue (no analysis of the broken fragments possible).In addition, there are further circumstances on the conditions in dentistry (used disinfectants, training/knowledge status), or any other environmental conditions, which are unknown to us and may also have an impact on the reported failure mode.Correlation between adverse event and the involved medical devices: indeterminate.The important information of adverse event is incomplete or unavailable, and the cause of adverse events of medical devices cannot be determined.

• 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: 22132179
• Report Number: 9611053-2025-00062
• Device Sequence Number: 20925681
• 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
• Report Date (Section B): 09/04/2025

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: 429738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/30/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown