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
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The 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 refill ring broke during use.
Additional Manufacturer Narrative
Investigation results: return - (b)(6) 2025: product not returned, image in case depicts 1 v3 palodent universal blue ring (new and improved v5 design) with broken tyne.Overmolding date codes couldn¿t be completely verified as the image does not clearly show the month molded, however the year is visible and reads ¿o¿ for 2023.Dhr and retain evaluation will be conducted.Note that the suspect product does not trace back to item# 659760v lot# 09323412 as this product was manufactured in 12-2024 (date codes would be ¿l¿ for (b)(6) and ¿p¿ for 2024) however, due to the nature of the case, dhr and retain evaluation will be documented for item# 659760v lot# 09323412.(nwv).Retain 11-13-2025: final product retains are not kept as per normal procedure.Retains from overmolding item# 759870 lot#¿s 09261537, 09261538 & 09329082 were reviewed and inspected per 0290-ip-7.5-60-58 and were found acceptable.(nwv).Dhr (b)(6) 2025: dhr for item# 659760v lot# 09323412 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 (b)(4) (produced (b)(6) 2024), (b)(4) (produced (b)(6) 2024) & (b)(4) (produced (b)(6) 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.(nwv).

• 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: 23528522
• Report Number: 2515379-2025-00030
• Device Sequence Number: 10186496
• Product Code: DZN
• UDI-Device Identifier: D002659760V1
• UDI-Public: D002659760V1
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 11/14/2025

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: 9323412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/06/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown