iBur 8431-107-030DRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327509229), received between Dec 23, 2021 and Jan 23, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 24, 2024Completed

   Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.

   Z-2730-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31, 2025. 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 24163993 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399924 ↗
• MalfunctionJul 8, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN THE TIP OF THE BUR WAS BURNT DURING AN ENDOSCOPIC TRANSNASAL PITUITARY TUMOR RESECTION THE TIP OVERHEATED AND BECAME BURNT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19694964 ↗
• MalfunctionNov 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE DURING USE. IT WAS ALSO REPORTED THE EVENT CAUSED A 90 MINUTE DELAY TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES THE SECOND INSTANCE OF THE BUR BREAK WHICH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192599 ↗
• MalfunctionNov 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE DURING USE. IT WAS ALSO REPORTED THE EVENT CAUSED A 90 MINUTE DELAY TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION 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 18192598 ↗
• MalfunctionJul 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE BUR BROKE. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED A DELAY OF LESS THAN 5 MINUTES. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304939 ↗
• MalfunctionDec 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BUR BROKE . 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13076948 ↗