NA 5820103017Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540362438), received between Jul 24, 2018 and Jul 29, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647295 ↗
• MalfunctionOct 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501546 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985894 ↗
• MalfunctionJun 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12086194 ↗
• MalfunctionMar 1, 2021Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING A SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11393583 ↗
• InjuryJun 22, 2020Fracture; Fracture

  IT WAS REPORTED THAT AFTER A CRANIOTOMY PROCEDURE, A SURGEON NOTICED A METAL FRAGMENT IN THE SKULL BONE ON A CT IMAGE. IT WAS ALSO REPORTED THAT THE SURGEON PERFORMED A SURGERY TO REMOVE THE FRAGMENT THE NEXT DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10178414 ↗
• InjuryJun 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE DRILL BIT BROKE AND REMAINED INSIDE THE PATIENT¿S SKULL BONE. IT WAS ALSO REPORTED THAT THE SURGEON DID NOT REALIZE THE BREAKAGE AT THE TIME. IT WAS FURTHER REPORTED THAT A WEEK LATER, A REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN FRAGMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10153394 ↗
• MalfunctionJul 24, 2018Break; Break

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE BROKE DURING USE. THERE WAS PATIENT INVOLVEMENT. TWO EVENTS OCCURRED DURING A CRANIAL PROCEDURE, 1 EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7714599 ↗