MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES E3 TORQUE CONTROL MOTOR

Catalog Number E3KIT

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

In this event a doctor reported that an e3 motor would not function in the reciprocating mode, possibly causing two files to break.The doctor was asked to calibrate the unit, which he did without issues.Afterwards, the motor was reciprocating properly.

Manufacturer Narrative

It is likely that because the motor was not reciprocating, that the doctor completed the treatment in another mode, such as rotary mode.If reciprocating files are driven in rotary mode the risk for breakage is high because the torque is not controlled.Further, rotary mode is in general the wrong movement for the file type.However, because the evaluation of the unit involved is not complete as of this report and 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, it must be presumed that the device malfunctioned and that the malfunction would be likely to cause/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
• Manufacturer (Section D): DENTSPLY TULSA DENTAL SPECIALTIES; johnson city TN
• Manufacturer (Section G): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich 8173 7; GM 81737
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w; 221 w philadelphia st, ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 3955724
• MDR Text Key: 4560134
• Report Number: 9611053-2014-00001
• 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: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• 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
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1