MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 UNIV 2 RING REFIL; INSTRUMENTS, DENTAL HAND

Catalog Number	659760V
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
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.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 palodent v3 univ 2 ring refil broke during use.No injury occurred.
Additional Manufacturer Narrative
Return 10-10-2025: product not returned, image in case depicts 1 v3 palodent universal blue ring (new and improved v5 design) with a broken tyne.Over molding date codes verified ¿i¿ for september and ¿p¿ for 2024.Dhr and retain evaluation will be conducted.(b)(6).Retain 10-10-2025: final product retains are not kept as per normal procedure.Retains from over molding item#: 759870, lot#¿s: 08961157, 08961158 & 08961159 were reviewed and inspected per 0290-ip-7.5-60-58 and were found acceptable.(b)(6).Dhr 10-10-2025: dhr for item#: 659760v, lot#: 08959600 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 univ 2 ring refil.Work order: (b)(4) is the packaging work order which utilized 3 over-molding of the springs to rings production work orders/runs of item: 759870 (v5 ring universal - palodent) lots in which were 08961157 (produced 09-2024), 08961158 (produced 09-2024) & 08961159 (produced 09-2024).Dhrs for each molding work order have also been pulled, reviewed, and attached to this case.Dhr review did not identify any issued during production with all inspections performed and deemed acceptable by the operator(s) and quality as per 0290-wi-7.5-60-14 & 0290-ip-7.5-60-58.(b)(6).

• Brand Name: PALODENT V3 UNIV 2 RING REFIL
• 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: 22813675
• Report Number: 2515379-2025-00017
• Device Sequence Number: 12190777
• Product Code: DZN
• UDI-Device Identifier: D002659760V1
• UDI-Public: D002659760V1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/13/2025

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: 659760V
• Device Lot Number: 08959600
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown