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

Catalog Number WGSMALL25

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problems Pain (1994); Apicectomy (2372); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

This submission is for the 4q17 asr serious injury events for rotary niti file breakage under asr exemption # 2007004.This report summarizes five serious injury events where a file broke (device problem code: 1069).There were five events where the broken piece could not be retrieved which remained in patients root canals and the broken piece was incorporated into the filling (patient problem code: 3165).In two of these five events, patients' required an apicectomy (patient problem code: 2372).In one of these five events, a patient experienced pain (patient problem code: 1994).Three devices were not returned for evaluation, one of which was because it was discarded by the user.We received two devices for evaluation, one of which was unused.Evaluation of the used device found it was broken at the shaft (device problem code: 955) and it was a single use device that was reused (device problem code: 1670).Evaluation of the unused device found it to be within specification.

Event Description

This report summarizes 5 reported events.This submission is for the 4q17 asr serious injury events for rotary niti file breakage.This report summarizes five serious injury events.There were five events where the broken piece could not be retrieved which remained in patients root canals and the broken piece was incorporated into the filling.In two of these five events, patients' required an apicectomy.In one of these five events, a patient experienced pain.

• 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: 7231162
• MDR Text Key: 98679525
• Report Number: 2320721-2017-00087
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• 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
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1