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

Catalog Number 659760V

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that palodent v3 univ 2 ring refil broke during use.No injury.

Manufacturer Narrative

Investigation: failure mode: broken product.Root cause: not determined.Conclusion code: indeterminable.Return: on 3-20-2024: returned product 1 v3 universal ring (blue, new and improved v5 version) broken in half at the pivot point.Overmolding date codes ¿b¿ for february and ¿o¿ for 2023.Dhr and retain evaluation to be conducted.(nwv) retain: on 3-20-2024: 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-rng-springs (spring processing) & 0290-ip-7.5-60-58 (over-molded rings).(nwv) dhr: on 3-20-2024: dhr for item# 659760v, batch# 06196973 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 06196973 is the packaging work order which utilized 2 different over-molding of the springs to rings production work orders/runs for item# 759870, batches 06259259 & 06259260 (v5 ring universal ¿ palodent).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, batch# 06259259 utilized spring processing item# 120011, batch# 06134003 & item# 759870, batch# 06259260 utilized spring processing item# 120011, batch# 06134004.Dhrs for spring processing work orders have also been pulled, reviewed, and attached to this case as well.Spring processing dhrs did indicate any production issues for both dhrs as the printable graph for the heat treatment cycle graphs were not able to be retrieved from dickson one online as documented in nc-2023-260 (originally nc-2023-255 however this record was void due to system error so new record was opened).All inspections however 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-rng-springs.Nc-2023-260 was accepted by concession and this is the first reported product failure for any batch associated with this nc.(nwv).

• Brand Name: PALODENT V3 UNIV 2 RING REFIL
• Type of Device: 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18793662
• MDR Text Key: 337084232
• Report Number: 2515379-2024-00013
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 659760V
• Device Lot Number: 06196973
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/27/2024
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1