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

Model Number 557 SWIVEL

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Tooth Fracture (2428)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

No material or workmanship defects were identified during the evaluation.The dental bur returned with the handpiece was also evaluated.Shank diameter measured 0.0627 inches.Slight torsional slipping was evident in the chuck gripping area.The working end had been damaged; cutting tip had broken off and the tapered portion was deformed to an approximately 60 degree angle to the axis.Microscope inspection of the fractured working end identified a spiral shaped break and variation in grain size.Conclusion: bur tool working end base material strength was exceeded by the combined torsional and lateral stress applied during use which lead to the tip failure and subsequent deformation.

Event Description

When operating on a patient the bur split apart and it ended up chipping another tooth he was not working on.He fixed the chipped tooth during the same procedure.The doctor sent the handpiece in with a note for repair.When the lares service representative called the doctor he indicated he did not know what the date of the event was or the patient's name.

• 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: 6520675
• MDR Text Key: 73669079
• Report Number: 2916440-2017-00004
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 557 SWIVEL
• Device Catalogue Number: 10124-235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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