NA 5300020901Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613153001126), received between Mar 16, 2018 and Jan 10, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE RESULTING IN A DELAY OF FORTY FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134728 ↗
• MalfunctionJan 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE RESULTING IN A DELAY OF FORTY FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE SECOND BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134723 ↗
• MalfunctionJan 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, AT THE START OF ROTATION OF THE BUR, THE BUR BROKE CLEANLY INTO THREE PIECES. IT WAS ALSO REPORTED THAT A SECOND BUR WAS USED AND IT ALSO BROKE INTO TWO PIECES, RESULTING IN A DELAY OF FORTY FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP DEVICE; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE SECOND BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113937 ↗
• MalfunctionJan 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, AT THE START OF ROTATION OF THE BUR, THE BUR BROKE CLEANLY INTO THREE PIECES. IT WAS ALSO REPORTED THAT A SECOND BUR WAS USED AND IT ALSO BROKE INTO TWO PIECES, RESULTING IN A DELAY OF FORTY FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP DEVICE; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113936 ↗
• MalfunctionDec 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THAT TWO BURS BROKE RESULTING IN A DELAY OF FORTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964970 ↗
• MalfunctionMar 16, 2018Break; Break

  IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN BUR WAS FOUND INSIDE THE ATTACHMENT. 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 Patient Involvement

  MAUDE report 7344811 ↗