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

Catalog Number	403343
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
In this event it is reported that v3 ring narrow (yellow) 2 pack broke during use.No injury occurred.
Additional Manufacturer Narrative
Investigation results: 11-7-2024: returned product 1 triodent v3 ring narrow yellow (older v3 design) broken in half a the pivot point.Overmolding date codes verified ¿d¿ for april and ¿i¿ for 2019.The returned product was produced 04-2019 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# 403343 lot# 08263787 attached as supporting evidence which shows the order was packaged in 3-2024 and does not trace to the returned product.(nwv).

• Brand Name: V3 RING NARROW (YELLOW) 2 PACK
• 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: 20166270
• Report Number: 2515379-2024-00044
• Device Sequence Number: 8138114
• Product Code: DZN
• UDI-Device Identifier: D002659900V1
• UDI-Public: D002659900V1
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 403343
• Device Lot Number: 08263787
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown