MAUDE Adverse Event Report: DENTSPLY LLC V3 SUPERCURVE KIT; INSTRUMENTS, DENTAL HAND

Catalog Number 403316

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, 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.

Event Description

In this event it is reported that a v3 super curve kit broke during use.No injury.

Manufacturer Narrative

Dhr review: 4-7-2023: dhr for item# 403316 lot# 05243873 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the v3 surpercurve kit.Work order 05243873 is the packaging work order which utilized 2 different v3 universal over-molding of the springs to rings production work orders/runs item# 220004 in which were 05104834 (produced 02-2022) & 05207432 (produced 02-2022).Dhrs for each of these molding work orders have 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).4-7-2023: final product retains are not kept as per normal procedure.Retains from each overmolding lot of universal rings 05104834 & 05207432 were reviewed and inspected per 0290-ip-7.5-60-58 and were found acceptable.(nwv).

• Brand Name: V3 SUPERCURVE KIT
• 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: 16367854
• MDR Text Key: 309466302
• Report Number: 2515379-2023-00062
• Device Sequence Number: 1
• Product Code: DZN
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 403316
• Device Lot Number: 05243873
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/10/2023
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1