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 is available for evaluation, though results are not available 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 - both rings broke off during treatment.No injury.
Additional Manufacturer Narrative
Investigation results: return.Returned product 1 v3 palodent universal ring (blue, new and improved v5 version) broken in half at the pivot point.Overmolding date codes ¿l¿ for december and ¿p¿ for 2024.Dhr and retain evaluation to be conducted.(nwv).Retain: final packaging product retains are not kept as per normal procedure.Ring over-molding & spring processing retains were reviewed and meet all inspection and functional criteria (first shot retains from each order where the quality techs have already tested/verified) as per 0290-ip-7.5-60-72 (spring processing) & 0290-ip-7.5-60-58 (over-molded rings).(nwv).Dhr: dhr for item#: 659760v, lot#: 09739335 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 5 different over-molding of the springs to rings production work orders/runs for item#: 759870 (v5 ring universal ¿ palodent) lot#¿s: 09329085 (manufactured 12-2024), 09329086 (manufactured 12-2024), 09329088 (manufactured 12-2024), 09329090 (manufactured 12-2024) & 09329091 (manufactured 12-2024).The over-molding work order is only to mold the tynes to the spring.Dhr reviews for both molding work orders did not indicate any production issues, nor any comments noted with all inspections performed and deemed acceptable by the operator(s) and quality as per 0290-ip-7.5-60-58.The springs themselves get processed on a different production work orders.The over-molding work order item#: 759870, lot#: 09329085 utilized spring processing item#: 120011, lot#: 09330835; item#: 759870, lot#: 09329086 utilized spring processing item#: 120011, lot#: 09330836; item#: 759870, lot#: 09329088 utilized spring processing item#: 120011, lot#: 09330838; item#: 759870, lot#: 09329090 utilized spring processing item#: 120011, lot#: 09330840 & item#: 759870, lot#: 09329091 utilized spring processing item#: 120011, lot#: 09330841.Dhrs for spring processing work orders have also been pulled, reviewed, and attached to this case as well.Spring processing dhrs did not indication any production issues, with all inspections were performed and deemed acceptable by the operator(s) and quality and meet all inspection/testing criteria including dimensional & functional specifications as per 0290-ip-7.5-60-72.(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: 22458364
• Report Number: 2515379-2025-00014
• Device Sequence Number: 12800958
• Product Code: DZN
• UDI-Device Identifier: D002659760V1
• UDI-Public: D002659760V1
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 09739335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown