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  

Event Description

In this event it is reported that a v3 supercurve broke during use.No injury occurred.

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.

Manufacturer Narrative

Investigation results: 4-7-2023: returned product v3 ring narrow yellow (new improved v5 ring) with broken tyne.Overmolding id ¿d¿ april & ¿n¿ 2022.Product does not meet specification, dhr review/retain evaluation to occur.(nwv) dhr review: 4-7-2023: dhr for item# 403316 lot# 05623250 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the v3 supercurve kit.Work order (b)(4) is the packaging work order which utilized 2 different over-molding of the springs to rings production work orders/runs in which are (b)(4) (produced 04-2022) & (b)(4) (produced 04-2022).Dhrs for each of these molding work orders have also been pulled, reviewed, and attached to this case.Dhr reviews did indicate contamination issues in production, however the overmolding plastic is removed and re-overmolded as part of normal process.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.Ring over-molding retains from batches (b)(4) were pulled, reviewed, and deemed acceptable as per 0290-ip-7.5-60-58 and meet all form/fit/function.(nwv) root cause: not determined.

• 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: 16565054
• MDR Text Key: 311586755
• Report Number: 2515379-2023-00065
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 403316
• Device Lot Number: 05623250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/14/2023
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1