N/A 5820110060CRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327294972), received between Feb 23, 2017 and Apr 22, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Vibration

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: VIBRATION. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953798 ↗
• MalfunctionJun 26, 2024Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT THE METAL FRAGMENTS WERE INSIDE THE PACKAGING WHEN IT WAS RECEIVED AT THE FACILITY. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613655 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557305 ↗
• MalfunctionNov 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 15747897 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BUR BROKE AT THE NOTCH. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 15536976 ↗
• MalfunctionJun 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A MASTOIDECTOMY PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 14687001 ↗
• MalfunctionMay 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE AT THE NOTCH END. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 11871800 ↗
• MalfunctionFeb 19, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE IN THE ATTACHMENT. IT WAS ALSO 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 8351741 ↗
• MalfunctionFeb 23, 2017Break; Break

  IT WAS REPORTED THAT DURING A LAMINECTOMY SURGICAL PROCEDURE, THE BUR BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A SHORT DELAY DELAY TO OBTAIN AN ALTERNATIVE DEVICE. IT WAS ALSO REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6352182 ↗