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

Catalog Number	659770V
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 is available for evaluation, though has not been returned 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 narrow 2 ring refl broke during use.The outcome of this event is unknown as of this mdr.Further information requested.
Additional Manufacturer Narrative
Returned product 1 palodent narrow dark blue v3 ring (new and improved v5 version) with 2 broken tynes.Overmolding date codes verified ¿f¿ for june and ¿n¿ for 2022.Final packaging product retains are not kept as per normal procedure.Ring over-molding 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-7.5-60-58 (over-molded rings).Dhr for item# 659770v lot# 05623994 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 narrow 2 ring refil.Work order (b)(4) is the packaging work order which utilized 2 different over-molding of the springs to rings production work orders/runs for item# 759880 (v5 ring narrow ¿ palodent) lots 05512218 (manufactured 06-2022) & 05625025 (manufactured 06-2022).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.

• Brand Name: PALODENT V3 NARROW 2 RING REFL
• 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: 19735236
• Report Number: 2515379-2024-00032
• Device Sequence Number: 15263818
• Product Code: DZN
• UDI-Device Identifier: D002659770V1
• UDI-Public: D002659770V1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/01/2024

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: 659770V
• Device Lot Number: 05623994
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/10/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown