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 broke during use.No injury occurred.
Additional Manufacturer Narrative
Investigation return.12-15-2025: returned product 1 palodent v3 ring universal blue (new and improved v5 design) broken in half at the pivot point.Overmolding date codes verified ¿c¿ for march and ¿q¿ for 2025.Product does not meet specifications therefore dhr and retain evaluation will be conducted.(b)(4).Retain.12-15-2025: final packaging product retains are not kept as per normal procedure.Ring over-molding retain from item# 759870 lot#¿s 09963998 & 09963999 were pulled, reviewed, and deemed acceptable as per (b)(4) and meet all form/fit/function.(b)(4).Dhr.12-15-2025: dhr for item# 659760v lot# 10297441 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 2 over-molding of the springs to rings production work orders/runs for item# 759870 v5 ring universal ¿ palodent in which were lot#¿s 09963998 (mfg 03-2025) & 09963999 (mfg 03-2025).The over-molding work order is only to mold the tynes to the spring.Dhr review for item# 759870 lot#¿s 09963998 & 09963999 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 (b)(4).The over molded rings utilize item# 120011 v3 spring universal sub assembled in which are processed on a separate work order.Dhrs for item# 120011 lot# 09980657 (spring used on work order# (b)(4)) and item# 120011 lot# 09980658 (spring used on work order# (b)(4)) did not indicate any issues during production, with all acceptance criteria met for both work orders as per (b)(4).

• 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: 23464294
• Report Number: 2515379-2025-00029
• Device Sequence Number: 18709321
• 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): 12/30/2025

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: 10297441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/03/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown