NA 511.73Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982237668), received between Dec 31, 2024 and Dec 31, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Complete Loss of Power” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CHUCK WITH KEY DEVICE WAS FROZEN/WILL NOT MOVE- CHUCK SEIZED, THE ETCHING WAS ILLEGIBLE, AND THE DEVICE HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKINGS, CHECK FUNCTION OF DRILL CHUCK SLEEVE, CHECK DRILL CHUCK IN SMALLEST RANGE, CHECK DRILL CHUCK IN BIGGEST RANGE, CHECK CANNULATION OF DRILL CHUCK, AND CHECK HANDPIECE COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048986 ↗