N/A 8450107525Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327097016), received between Feb 22, 2018 and Mar 9, 2023 — 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.

• MalfunctionMar 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES, OR NO DELAYS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519462 ↗
• MalfunctionOct 21, 2022Fracture; Fracture

  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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15652107 ↗
• MalfunctionAug 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A LAMINECTOMY PROCEDURE, THE BUR BROKE AT THE TIP. 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 15264696 ↗
• MalfunctionJun 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE IN HALF. 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 Consequences Or Impact To Patient

  MAUDE report 10153392 ↗
• MalfunctionSep 12, 2019Break; Fracture; Overheating of Device; Break; Fracture; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A DEVICE GOT HOT AND BURNED THE DOCTORS HAND. IT WAS ALSO REPORTED THAT THE BUR BROKE IN THE ATTACHMENT. IT WAS FURTHER REPORTED THE BURN DID NOT REQUIRE MEDICAL INTERVENTION. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE EVENT DID NOT CAUSE A DELAY.

  Patient problems: No Consequences Or Impact To Patient; Superficial (First Degree) Burn

  MAUDE report 9014034 ↗
• MalfunctionJun 13, 2019Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGEON USED AN EXPIRED BUR. 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 8696360 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE NURSE RECEIVED A MINOR FINGER BURN, NO TREATMENT WAS REQUIRED FOR THE BURN. IT WAS ALSO REPORTED THAT THE BUR BROKE IN HALF. IT WAS FURTHER REPORTED THAT THERE WAS A ONE MINUTE DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Burn(s)

  MAUDE report 8175241 ↗
• MalfunctionJul 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 7691364 ↗
• MalfunctionFeb 22, 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 7289531 ↗