MAUDE Adverse Event Report: DENTSPLY CAULK PALODENT V3 FORCEPS; INSTRUMENTS, DENTAL HAND

Catalog Number 659700V

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a pair of palodent v3 forceps broke at the tip; no injury resulted.

Manufacturer Narrative

Evaluation confirmed the device is broken as indicated in the complaint.Root causes not identified.Will continue to track and trend.

• Brand Name: PALODENT V3 FORCEPS
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• MDR Report Key: 8364924
• MDR Text Key: 137460983
• Report Number: 2515379-2019-00001
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 659700V
• Device Lot Number: A1117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1