MAUDE Adverse Event Report: LARES RESEARCH LARES RESEARCH; HIGH SPEED AIR POWERED DENTAL HANDPIECE

Model Number PRECISION TORQUE PUSH BUTTON

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Tooth Fracture (2428)

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

Visual examination of returned product confirmed a round carbide bur secured in the handpiece and was bent at approximately 60 degree angle to its axis.Exposed bur shank surfaces showed signs of clamping deformation (flat spots).Functionally the when the button was depressed the bur would not release.Turbine assembly was removed from the handpiece and a tool was applied to the turbine to increase the applied force on the chuck.The chuck taper released with the applied force and the bur was extracted from the spindle.Bur shank marks were indicative of bur slipping in the chuck (at least one full rotation) and raised material prevented bur removal by hand.

Event Description

The handpiece made a really loud noise and the operator noticed the crown had broken so they had to do an extraction and implant.No medical attention was required, patient was fine.

• Brand Name: LARES RESEARCH
• Type of Device: HIGH SPEED AIR POWERED DENTAL HANDPIECE
• Manufacturer (Section D): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• Manufacturer (Section G): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• Manufacturer Contact: bruce holderbein ; 295 lockheed avenue; chico, CA 95973 ; 5303451767
• MDR Report Key: 6553076
• MDR Text Key: 74743394
• Report Number: 2916440-2017-00005
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780038
• 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: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: PRECISION TORQUE PUSH BUTTON
• Device Catalogue Number: 10064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1