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

Catalog Number V040007025711

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

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This submission is for the 1q18 asr malfunction events for rotary niti file breakage under asr exemption # 2007004.This report summarizes 124 malfunction events where a file broke (device problem code: 1069).In 23 events, the file was reported to have broken at the shaft (device problem code: 955).In 26 events, the file was reported to have broken at the tip (device problem code: 3123).In 75 events, it was not specified where the break occurred on the device.There were 72 events where file breakage resulted in no consequences or impact to the patient (patient problem code: 2199).There were 45 events where the patient outcome is unknown despite multiple attempts to obtain the information (patient problem code: 3190).There were seven events where the broken piece was still in patients' root canals, but root canal treatment was not yet complete and multiple attempts to obtain additional information were unsuccessful (patient problem code: 3165 and 2687).50 devices were not returned for evaluation, of which 16 were because they were discarded by the user.54 devices were received in a condition making evaluation impossible.20 unused devices were received for evlatuion and all were found to be within specification.

Event Description

This report summarizes 124 reported events.This submission is for the 1q18 asr malfunction events for rotary niti file breakage.This report summarizes 124 malfunction events where a file broke.There were 72 events where file breakage resulted in no consequences or impact to the patient.There were 45 events where the patient outcome is unknown despite multiple attempts to obtain the information.There were seven events where the broken piece was still in patients' root canals, but root canal treatment was not yet complete and multiple attempts to obtain additional information were unsuccessful.

• 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: 7474103
• MDR Text Key: 106957075
• Report Number: 2320721-2018-00027
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Number of Events Reported: 124
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: V040007025711
• Was the Report Sent to FDA?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1