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

Catalog Number WGSMALL25

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

This submission is for the 3q17 asr malfunction events for rotary niti file breakage under asr exemption # 2007004.This report summarizes 99 malfunction events.There were 85 events where file breakage resulted in no consequences or impact to the patient.There were 14 events where the patient outcome is unknown despite multiple attempts to obtain the information.Forty-three (43) of the devices were not returned for evaluation.We received 56 of the 99 devices for evaluation, of which: sixteen (16) of the devices were found to be within specification.Forty (40) of the devices were received in a condition making evaluation impossible.

Event Description

This submission is for the 3q17 asr malfunction events for rotary niti file breakage.This report summarizes 99 malfunction events.There were 85 events where file breakage resulted in no consequences or impact to the patient.There were 14 events where the patient outcome is unknown despite multiple attempts to obtain the information.

• 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: 6982922
• MDR Text Key: 91095843
• Report Number: 2320721-2017-00065
• 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

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: WGSMALL25
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1