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  

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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

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 results: return on 8-24-2023: product not returned; images in case shows a v3 universal ring (v5 version) with one of the overmolding tynes broken off confirming the customers complaint.Overmolding date codes could verified ¿b¿ february and ¿o¿ 2023 with image provided, which does not trace back to the batch identified in this case (overmolding for the 2 batches used to kit item# 659760v lot# 06592904 were produced in march 2023 and would have overmolding date codes of ¿c¿ for march and ¿o¿ for 2023).Dhr and retain evaluation will be conducted for batch provided in the case.(nwv) retain on 8-24-2023: final product retains are not kept as per normal procedure.Retains from overmolding item# 759870 batches 06474427 & 06474428 were reviewed and inspected per 0290-ip-7.5-60-58 and were found acceptable.(nwv).Dhr on 8-24-2023: dhr for item# 659760v lot# 06592904 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 (v5 ring universal - palodent) in which were (b)(4) (produced 03-2023) & (b)(4) (produced 03-2023).Dhrs for each molding work order have also been pulled, reviewed, and attached to this case.Dhr review did not identify any issues during the production work orders 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: 17564863
• MDR Text Key: 321346543
• Report Number: 2515379-2023-00090
• Device Sequence Number: 1
• Product Code: DZN
• UDI-Device Identifier: D002659760V1
• UDI-Public: D002659760V1
• 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: 09/14/2023

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: 659760V
• Device Lot Number: 652904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/17/2023
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1