MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES ROTARY NITI FILES; FILE, PULP CANAL, ENDODONTIC

Catalog Number WGSMALL25

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

This submission is for the 3q17 asr serious injury events for rotary niti file breakage under asr exemption # 2007004.This report summarizes three serious injury events.There were three events where the broken piece could not be retrieved which remained in patients root canals and the broken piece was incorporated into the filling.One device was not returned for evaluation.We received two of the three devices for evaluation, which were received in a condition making evaluation impossible.

Event Description

This submission is for the 3q17 asr serious injury events for rotary niti file breakage.This report summarizes three serious injury events.There were three events where the broken piece could not be retrieved which remained in patients root canals and the broken piece was incorporated into the filling.

• Brand Name: ROTARY NITI FILES
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6982929
• MDR Text Key: 90405353
• Report Number: 2320721-2017-00064
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: WGSMALL25
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1