MAUDE Adverse Event Report: DENTSPLY CAULK PALODENT V3 RING; 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, 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.Returned product was one palodent v3 ring universal.The ring returned was broken in half at the pivot point (center) with overmolding identifications as "i." for 2019 and "f" for june.Per the useful life of the device at 2 years from date of manufacture the complaint is considered not substantiated as the ifu states automated disinfection up to 500x and sterilization process up to 1000x, which is equivalent to 2 years of use.

Event Description

In this event it was reported that a palodent v3 matrix ring broke during use; no injury resulted.

• Brand Name: PALODENT V3 RING
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer (Section G): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer Contact: joleta ness ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 12368909
• MDR Text Key: 268212336
• Report Number: 2515379-2021-00017
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• 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
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 659760V
• Device Lot Number: 01111144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1