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
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 21 cfr 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 an eddy irrigation tip broke.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Investigation results: we received 13 unused tips and one broken eddy tip (2 pieces) for investigation.Visual inspection of broken eddy tip: the tip is separated between the handle part and the active part.Measurement: active part is measuring approx.27,04 mm.The tip of the active part is not complete; the tip is missing¿ see photos) (measured with measuring gauge mitutoyo pm # 1749 valid till 5/2026).Injection tool cavity is #2; see attached photos.Investigation results of 13 unused tips inside blister: performance test of the undamaged product was performed.All 13 unused tips passed the test without issues.Dhr review for the claimed lot 476602 was performed by mc2 (no dhr issue was detected ¿ see attachment to case).Root cause unknown.Misuse possible.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.Update results: no smooth breakage, melted.Breakage due to thermal influence - possible misuse.Attached results - confirmed by mc1.

• 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: 23567941
• Report Number: 9611053-2025-00160
• Device Sequence Number: 21362311
• Product Code: EIC
• UDI-Device Identifier: 07640159160090
• UDI-Public: 07640159160090
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 02/25/2026

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: 476602
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/05/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown