MAUDE Adverse Event Report: DENTSPLY LTD TRIODENT FORCEPS

Catalog Number 402061

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

While no serious injury resulted in this event, there has been a previous report received with a similar device where this malfunction resulted in a serious injury; therefore, this event meets the criteria for reportability per 21 cft part 803.The device is available for eval, though has not been returned as of this report.Eval results will be submitted as they become available.

• Brand Name: TRIODENT FORCEPS
• Manufacturer (Section D): DENTSPLY LTD; katikati ; NZ
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w; 221 w philadelphia st ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4281402
• MDR Text Key: 5033577
• Report Number: 3003959465-2014-00004
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2014
• 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: 014729
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1