MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 UNIV 2 RING REFIL; INSTRUMENTS, DENTAL HAND

Catalog Number 659760V

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 palodent v3 univ 2 ring refil broke during use.No injury occurred.

Manufacturer Narrative

Investigation findings: 1-23-2023: product not returned but image of v3 ring with a broken tyne was provided/attached in the case.The overmolding date id code for 1 side reads ¿g¿ for july and ¿n¿ for 2022.Dhr and retain evaluation will be conducted.(nwv).Final product retains are not kept as per normal procedure.Retains from overmolding lot of universal rings batches (b)(4) were reviewed and inspected (b)(4) and were found acceptable.(nwv) dhr for lot# 05758799 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 univ 2 ring refil.Work order (b)(4) is the packaging work order which utilized 2 over-molding of the springs to rings production work orders/runs of item 759870 (universal ring) in which were (b)(4) (both produced 07-2022).Dhrs for molding work orders (b)(4) have also been pulled, reviewed, and attached to this case.Dhr reviews 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).

Manufacturer Narrative

Investigation results: 1.(b)(6) 2023: product not returned but image of v3 ring with a broken tyne was provided/attached in the case.The overmolding date id code for 1 side reads ¿g¿ for (b)(6) and ¿n¿ for 2022.Dhr and retain evaluation will be conducted.(nwv).2.(b)(6) 2023: final product retains are not kept as per normal procedure.Retains from overmolding lot of universal rings batches 05764633 & 05764634 were reviewed and inspected per 0290-ip-7.5-60-58 and were found acceptable.(nwv).3.(b)(6) 2023: dhr for lot# 05758799 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 univ 2 ring refill.Work order 05758799 is the packaging work order which utilized 2 over-molding of the springs to rings production work orders/runs of item 759870 (universal ring) in which were 05764633 & 05764634 (both produced (b)(6) 2022).Dhrs for molding work orders 05764633 & 05764634 have also been pulled, reviewed, and attached to this case.Dhr reviews 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).

• Brand Name: PALODENT V3 UNIV 2 RING REFIL
• 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: 16232025
• MDR Text Key: 308046190
• Report Number: 2515379-2023-00061
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 659760V
• Device Lot Number: 05758799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/18/2023
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1