MAUDE Adverse Event Report: DENTSPLY (N.Z.) LIMITED TRIODENT PLACEMENT FORCEPS; INSTRUMENTS, DENTAL HAND

Catalog Number 402061

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 triodent forceps broke at the tip; no injury resulted.

Manufacturer Narrative

Evaluation of the forceps using 30x magnification found scoring on the underside of the remaining tip.This type of defect is typical of poor manufacturing process in finishing.Forceps hardness results average = 48, which is within specification.

• Brand Name: TRIODENT PLACEMENT FORCEPS
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY (N.Z.) LIMITED; 11 marshall road; katikati, bay of plenty 3129 ; NZ 3129
• Manufacturer (Section G): DENTSPLY (N.Z.) LIMITED; 11 marshall road; katikati, bay of plenty 3129 ; NZ 3129
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5169529
• MDR Text Key: 29228253
• Report Number: 3003959465-2015-00002
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/25/2015

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: 402061
• Device Lot Number: A01113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2015
• Initial Date FDA Received: 10/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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