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	Insufficient Information (4580)
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 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 palodent v3 univ 2 ring refil broke during use.The outcome of this event is unknown as of this mdr.
Additional Manufacturer Narrative
Investigation result: 12-30-2024: product not returned, image in case depicts 1 v3 universal ring (v5 version) with the overmolding on one side broken off as the customer describes.Overmolding date codes could not be verified with the image attached (top view and not bottom view).Returned product does not meet specification, retains will be evaluated.(nwv).Retains: 12-30-2024: retains for item#: 659760v, lot#: 08122108 are not available for review as final product retains are not kept as per normal procedure.Retains from item#: 759870 (v5 ring universal ¿ palodent) lots: 07975160 & 08151423 were pulled and reviewed and inspected per 0290-ip-7.5-60-58 and functionally tested by using a pair of forceps opening completely, locking the bar, and observed for tension and return to memory once released from the forceps.All retain samples were found acceptable to specification and meet all form/fit/function requirements.(nwv).Dhr: 12-30-2024: dhr for item#: 659760v, lot#: 08122108 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 refill.Work order: (b)(4) is the packaging work order which utilized v3 universal over-molding of the springs to rings production work orders/runs item#: 759870 (v5 ring universal ¿ palodent) lot#: 08151423 (produced 03-2024) & lot#: 07975160 (produced 02-2024).Dhr for this molding work order has also been pulled, reviewed, and attached to this case.Dhr review did not indicate any issues in 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: 20639125
• Report Number: 2515379-2024-00052
• Device Sequence Number: 20700777
• 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): 01/03/2025

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: 02122108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown