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

Catalog Number 659810

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 plus forceps broke at the tip.The event outcome is unknown as of this mdr evaluation.Additional information is being requested.

Manufacturer Narrative

Product examined under 20 x magnification - left tip missing.Evidence would point to manufacturing forming and finishing as a root cause.Scar issued to original manufacturer to correct the issue.

• Brand Name: PALODENT PLUS FORCEPS
• 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: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5253735
• MDR Text Key: 32389661
• Report Number: 2515379-2015-00074
• 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,Followup
• Report Date: 10/28/2015

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 Operator: Health Professional
• Device Catalogue Number: 659810
• Device Lot Number: A1213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1