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)
Date of Event	10/23/2025
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 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 ring broke during use.No injury.
Additional Manufacturer Narrative
12-2-2025: returned product 1 palodent v3 ring universal blue (older v3 design) broken in half a the pivot point.Overmolding date codes verified ¿c¿ for march and ¿e.¿ for 2015.The returned product was produced 03-2015 which exceeds the 2 year useful life as per attached rationale email document (attached).Dhr and retain evaluation will not be conducted.Also note, the batch information provided does not trace back to the manufacturing date codes molded on the returned product.Dhr for item# 659760v lot# 07801334 attached as supporting evidence which shows the order was packaged in 1-2024 and does not trace to the returned product.(nwv).Failure mode - broken product.Root cause - out of lifetime.Conclusion code - expected wear.

• 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
• MDR Report Key: 23449944
• Report Number: 2515379-2025-00026
• Device Sequence Number: 21084622
• Product Code: DZN
• UDI-Device Identifier: D002659760V1
• UDI-Public: D002659760V1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/18/2025

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: 07801334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/29/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown