MAUDE Adverse Event Report: LARES RESEARCH SMOOTHDRIVE; HIGH-SPEED CONTRA ANGLE HANDPIECE

Model Number	1:5 CA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was tested at the manufacturer service depot and all performance measures meet new specifications.No material or manufacturing defects were noted.
Event or Problem Description
The customer indicated a bur came out of the handpiece during a procedure.The bur was retrieved and the patient was not affected.

• Brand Name: SMOOTHDRIVE
• Common Device Name: HIGH-SPEED CONTRA ANGLE 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: 19085324
• Report Number: 2916440-2024-00003
• Device Sequence Number: 7576121
• Product Code: EGS
• UDI-Device Identifier: D950135020
• UDI-Public: D950135020
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K220874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1:5 CA
• Device Catalogue Number: 13502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown