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)
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 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 3 eddy irrigation tips broke during use.Reportedly, no injury occurred.It is unknown how many patients are involved in this event.Further information requested.
Additional Manufacturer Narrative
Additional information received: in this case the surgeon updated us about the following: the eddy tips fractured immediately after unpacking upon initial contact with the tooth root.No fragments were visible in the root canal.Both eddy tips broke cleanly at the shaft.A second complaint has been opened for investigation.This is a follow up report for this additional information.Investigation results customer returned: 1 broken upper / under part and 6 unused eddy tips for investigation.Product investigation: broken tip has the cavi 1, product is broken at point 28mm working part.No smooth breakage, melted.Breakage due to thermal influence ¿ misuse.Measuring gauge: mitutoyo model cd 15cpx valid to 5 / 2026.Performance test of the undamaged product: passed.Investigation results confirmed by mc1.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.Dhr: nothing unusual to report was found during dhrs review.Nothing was changed in production process.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: 24245109
• Report Number: 9611053-2026-00031
• Device Sequence Number: 9618318
• Product Code: EIC
• UDI-Device Identifier: 07640159160090
• UDI-Public: 07640159160090
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 03/19/2026

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: 379527
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/27/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown