MAUDE Adverse Event Report: DENTSPLY LLC V3 RING NARROW (YELLOW) 2 PACK; INSTRUMENTS, DENTAL HAND

Catalog Number 403343

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 v3 ring narrow (yellow) 2 pack broke during use.No injury.

Manufacturer Narrative

2-23-2024: returned product 1 palodent v3 narrow ring (yellow, v5 version) overmodling date codes ¿b¿ for february and ¿n¿ for 2022 with one side of the overmolded plastic broken off of the metal spring as the customer describes.After further examination of the returned product, more specifically the condition of the plastic shows excessive damage/use which resulted in the plastic on one side becoming brittle and crack which allowed the entire plastic to fall off the product (images attached).Also note that the product was produced in 02-2022 and is just now reaching its total useful life of 2 years as per attached email rationale.No dhr or retain evaluation will be conducted as the batch information provided in this case for item# 403343 batch# 07365426 traces back to packaging/labeling production order which was conducted on 09-1-2023 which utilized component item# 220003 v5 ring narrow ¿ triodent batch# 06849804 which was produced/overmolded on 06-12-2023 and would have an overmolding date code of ¿f¿ for june and ¿o¿ for 2023 (dhrs attached for traceability).(nwv).

• Brand Name: V3 RING NARROW (YELLOW) 2 PACK
• 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: 18544350
• MDR Text Key: 333260349
• Report Number: 2515379-2024-00007
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D002659670V1
• UDI-Public: D002659670V1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 403343
• Device Lot Number: 07365426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/18/2024
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1