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
Event or Problem Description
In this event it is reported that v3 ring universal (green) 2 pack broke during use.No injury.
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.
Additional Manufacturer Narrative
(b)(6) 2024: returned product 1 palodent v3 universal ring (green, v5 version) overmodling date codes ¿j¿ for october and ¿n¿ for 2022.This ring observed to have the overmolding tynes on one side broken and also noticed not symmetrical to the other side (images attached) and does not meet specification as per 0290-ip-7.5-60-58.There is no batch information provided in this case, therefore no dhr or retain evaluation can be conducted.Nc-2024-606 issued for this non-conformance.(nwv) failure mode: broken product root cause: manufacturing error conclusion code: product failure - manufacturing.

• 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18542663
• Report Number: 2515379-2024-00005
• Device Sequence Number: 8903208
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/18/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown