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

Catalog Number 659770V

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, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event 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 palodent v3 narrow 2 ring refl broke during use.All broken parts were retrieved from patient's mouth.No injury occurred.

Manufacturer Narrative

Product not returned; however, an image of the suspect product has been provided.The image of the product shows a broken tine in the over molding of the universal ring.The product does not meet specification and is considered substantiated.Final product retains are not kept as per normal procedure.Retains from each over molding lot of universal rings were reviewed and inspected per 0290-ip-mold-rings and were found acceptable.Dhr review has been pulled and reviewed.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 starter kit.Work order 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 01-2022) & (b)(4) (produced 01-2022).Dhrs for each of these molding work orders have also been pulled and reviewed.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-mol-049 & 0290-ip-mold-rings.

• Brand Name: PALODENT V3 NARROW 2 RING REFL
• 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: 14804314
• MDR Text Key: 303295980
• Report Number: 2515379-2022-00046
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 659770V
• Device Lot Number: LOT FROM KIT: 05122460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/23/2022
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1