MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES E3 TORQUE CONTROL MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number E3KIT

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/23/2015

Event Type  malfunction  

Event Description

In this event it was reported that an e3 motor was not working properly and possibly caused three files to break in the same patient, in two different teeth.It is unknown if the separated pieces were retrieved.Follow up is not yet complete.

Manufacturer Narrative

Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The file separation events will be reported via asr, as appropriate.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

• Brand Name: E3 TORQUE CONTROL MOTOR
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): DENTSPLY TULSA DENTAL SPECIALTIES; johnson city TN
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commer center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4728076
• MDR Text Key: 5749685
• Report Number: 9611053-2015-00014
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E3KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1