MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROTAPER U ROTARY F2 21MM; DRILL, DENTAL, INTRAORAL

Catalog Number PTURF221

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 event outcome is unknown as of this mdr evaluation.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

It was reported that a protaper finishing file broke during use.The patient has been referred to a specialist to have the broken part removed.

Manufacturer Narrative

Additional information was received indicating that the broken portion of the file was retrieved from the patient's tooth.Involved protaper finishing f2 21mm that broke during use is not available and cannot be analyzed by our laboratory.Unused products have been evaluated according to our prescriptions and were found in compliance with specifications (measures, torque test).A dhr review was conducted with no discrepancies noted (batch #1477152).Root causes are not identified.This kind of event is tracked and we monitor the trend.

• Brand Name: PROTAPER U ROTARY F2 21MM
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• MDR Report Key: 8473414
• MDR Text Key: 140640103
• Report Number: 2320721-2019-00049
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTURF221
• Device Lot Number: 1477152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Date Manufacturer Received: 04/18/2019
• Patient Sequence Number: 1