MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROTAPER GOLD ROTARY SX 19MM; DRILL, DENTAL, INTRAORAL

Catalog Number PTGRSX19

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

In this event it was reported that a protaper gold file broke during use.The broken piece was not retrieved yet.The patient has an appointment in (b)(6) to have the broken part removed by the dentist.

Manufacturer Narrative

Additional information was received indicating that the broken portion of the file was retrieved from the patient's tooth.

• Brand Name: PROTAPER GOLD ROTARY SX 19MM
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• MDR Report Key: 8307722
• MDR Text Key: 135181132
• Report Number: 2320721-2019-00011
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

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: PTGRSX19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1