MAUDE Adverse Event Report: DENTSPLY LLC V3 RING UNIVERSAL (GREEN) 2 PACK; INSTRUMENTS, DENTAL HAND

Catalog Number	403342
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 21cfr part 803.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.Investigation: 1 triodent v3 universal ring returned with a broken tyne as the customer stated.Item is date coded "j" and "o" corresponding to an 08/2023 manufacturing date.Complaint substantiated based on returned product.Lot number not provided so dhr and retain investigations cannot be performed.Product returned with broken tyne as customer stated.Dhr/retain investigations not performed (missing lot info).
Event or Problem Description
In this event it is reported that v3 ring universal (green) 2 pack, ring broke.The outcome of this event is unknown as of this mdr.Further information requested.

• Brand Name: V3 RING UNIVERSAL (GREEN) 2 PACK
• Common Device Name: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 25185638
• Report Number: 2515379-2026-00051
• Device Sequence Number: 10702680
• Product Code: DZN
• UDI-Device Identifier: D002659900V1
• UDI-Public: D002659900V1
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 403342
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/21/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown