NA 5820103013Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540362414), received between Jul 24, 2018 and Jul 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25907851 ↗
• MalfunctionApr 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DRILL BIT WAS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION WERE REPORTED. IT IS UNKNOWN IF THERE WERE ANY ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS SUBSEQUENTLY REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794475 ↗
• MalfunctionMay 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT THE DRILL BROKE INSIDE THE PATIENT FOLLOWING CONSULTATION OF THE COMPUTED TOMOGRAPHY(CT) SCAN. IT WAS ALSO REPORTED THAT THE FRAGMENT OF THE DRILL WAS REMOVED SUCCESSFULLY FROM THE PATIENT. IT WAS FURTHER REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10043065 ↗
• MalfunctionJul 24, 2018Break; Break

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE BROKE DURING A CRANIOTOMY PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7714600 ↗