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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.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 a v3 ring universal (green) 2 broke during use.No injury.
Additional Manufacturer Narrative
Investigation results returned product 1 trident v3 ring universal green (new and improved design v5) with a broken tyne from one side of the ring.Overmolding date codes ¿e¿ for may and ¿q¿ for 2025.Returned product does not meet specifications.Dhr and retain evaluation will be conducted.Retains final product retains are not kept as per normal procedure.Retains from item # 220004 lot# 10236641 was reviewed and inspected per 0290-ip-7.5-60-58 and meet all inspection criteria.Dhr for item# 403342 lot# 10812041 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the v3 ring universal (green) 2 pack.Work order (b)(4) is the packaging work order which utilized over-molding of the springs to rings production work order/run of item # 220004 (v5 ring universal - trident) lot # 10236641 (produced (b)(6) 2025).Dhr for item # 220004 lot # 10236641 has also been pulled, reviewed, and attached to this case.Dhr reviews did not indicate any issues in production, with all inspections performed and deemed acceptable by the operator(s) as per 0290-wi-7.5-60-14 & 0290-ip-7.5-60-58.

• 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
• MDR Report Key: 24002415
• Report Number: 2515379-2026-00002
• Device Sequence Number: 18774365
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 403342
• Device Lot Number: 10812041
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/06/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown