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

Catalog Number 403342

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

In this event it is reported that v3 ring universal (green) 2 pack broke during use.No injury.

Manufacturer Narrative

While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, 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.

Manufacturer Narrative

Investigation: return (b)(6) 2024: product not returned; image in case depicts 2 palodent v3 universal ring (green, v5 version) overmodling date codes not visible with attached image.Both rings observed to have broken tynes causing the rings to no longer be functional.Dhr and retain evaluation to be conducted.(nwv) retain: (b)(6) 2024: final product retains are not kept as per normal procedure.Retains from overmolding lot of universal rings (b)(6) were reviewed and inspected per (b)(4) and were found acceptable.(nwv) dhr: (b)(6) 2024: dhr for item# 403342 lot# 06614879 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the v3 ring universal (green) 2 pack.Work order (b)(4) is the packaging work order which utilized 1 v3 universal over-molding of the springs to rings production work order/run item# 220004 in which was (b)(6) (produced 10-2022).Dhr for molding work order (b)(4) 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 (b)(4).(nwv).

• Brand Name: V3 RING UNIVERSAL (GREEN) 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: 18543009
• MDR Text Key: 333240523
• Report Number: 2515379-2024-00006
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D002659900V1
• UDI-Public: D002659900V1
• 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: 03/27/2024

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: 403342
• Device Lot Number: 06614879
• 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?: No
• Type of Device Usage: A
• Patient Sequence Number: 1