NA 5820103015Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04546540362421), received between Oct 24, 2018 and Apr 22, 2026 — classified as 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Fracture” (22 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Fracture

  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 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954017 ↗
• 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 24163401 ↗
• 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 1 EVENT FOR THE FAILURE: FRACTURE - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399965 ↗
• InjuryFeb 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THERE WERE NO IMMEDIATE CLINICAL CONSEQUENCES. PIECE NOT FOUND TO DATE, DESPITE SEVERAL INTRA-OPERATIVE AND POST-OPERATIVE OPERATION. A REQUEST WAS MADE FOR BRAIN SCAN TO VERIFY ABSENCE IN SURGICAL SITE. CURRENTLY WE ARE MAKING ATTEMPTS TO GET ADDITIONAL INFORMATION FROM THE REPORTER.

  Patient problems: Insufficient Information

  MAUDE report 21479653 ↗
• MalfunctionDec 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A MENINGIOMA SURGERY, THE STRYKER DRILL BIT BROKE. THE DRILL BIT WAS NOT IMMEDIATELY FOUND, BUT SIGNIFICANT BLEEDING WAS OBSERVED IN THE SUBDURAL SPACE, ALONG WITH AN INCREASE IN INTRACRANIAL PRESSURE AND THE ONSET OF CEREBRAL HERNIATION. THE 2 MM DRILL BIT FRACTURE WAS FOUND OPPOSITE A VEIN AND AN ARTERY AT THE END OF THE RIGHT SYLVIAN VALLEY. HEMOSTASIS WITH BIPOLAR FORCEPS, APPLICATION OF FLOSEAL AND TACHOSIL, ABSENCE OF ACTIVE BLEEDING AT THE END OF THE PROCEDURE. CLINICAL CONSEQUENCE AND PATIENT'S CURRENT CONDITION: RIGHT FRONTOTEMPORAL CORTICAL ARTERIAL AND VENOUS INJURY WITH SIGNIFICANT BLEEDING (EXACT BLOOD LOSS UNKNOWN), PROLONGED OPERATIVE TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Intracranial Pressure Increased

  MAUDE report 20938593 ↗
• MalfunctionOct 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - (B)(4) EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

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

  MAUDE report 20502213 ↗
• MalfunctionJul 24, 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 19817130 ↗
• MalfunctionFeb 22, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE BUR OVERHEATED, LEAVING A BLACK TRACE ON THE BONE FLAP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 18756636 ↗
• MalfunctionFeb 22, 2024Fracture; Overheating of Device; Fracture; Overheating of Device

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE BUR OVERHEATED, LEAVING A BLACK TRACE ON THE BONE FLAP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 18756635 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

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

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556907 ↗
• MalfunctionNov 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN EMERGENCY PROCEDURE FOR EVACUATION OF A TRAUMATIC LEFT EXTRADURAL HAEMATOMA, THE DRILL BIT BROKE WHILE MAKING THE HOLES IN THE PATIENT'S SKULL TO SUSPEND THE DURA. NO FURTHER INFORMATION WAS PROVIDED ON THE PATIENT OUTCOME.

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

  MAUDE report 18080510 ↗
• MalfunctionDec 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DRILL BIT BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15892832 ↗
• MalfunctionMay 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE DRILL BIT BROKE, THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT¿S BONE USING A HEMOSTAT. 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 14427995 ↗
• MalfunctionJul 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE BUR BROKE DURING AN INTRACRANIAL SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT DEBRIS WAS THROWN FROM THE DEVICE INTO THE ROOM. IT WAS FURTHER REPORTED THERE WAS A DELAY 5 MINUTES TO SWITCH TO ANOTHER DEVICE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245392 ↗
• MalfunctionJun 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOPLASTY SURGICAL PROCEDURE IN THE PATIENT¿S SKULL, THE DRILL BIT BROKE APPROXIMATELY 10MM FROM THE TIP AND THE FRAGMENT WAS EASILY REMOVED. 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 11923492 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BUR BROKE. IT WAS ALSO REPORTED THAT A BUR FRAGMENT WAS REMOVED FROM THE SURGICAL SITE. IT WAS FURTHER 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 11701891 ↗
• MalfunctionMar 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A CRANIOTOMY SURGICAL PROCEDURE, THE DRILL BROKE. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS DELAYED BY 05 MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424143 ↗
• InjuryDec 4, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL BIT BROKE. IT WAS ALSO REPORTED A REVISION SURGERY WAS REQUIRED TO REMOVE THE BROKEN DRILL BIT TIP FROM THE PATIENT. IT WAS FURTHER REPORTED A DELAY OF 15 MINUTES OCCURRED AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10949640 ↗
• MalfunctionAug 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIOTOMY SURGICAL PROCEDURE, THE DRILL BIT 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; No Consequences Or Impact To Patient

  MAUDE report 10373858 ↗
• MalfunctionMar 31, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING DURING OUT OF BOX INSPECTION. 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 9903056 ↗
• MalfunctionFeb 24, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL BIT BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9745767 ↗
• MalfunctionFeb 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE BUR BROKE AT THE SHANK DURING A CRANIOTOMY PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 9694383 ↗
• MalfunctionNov 27, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE WIRE PASS DRILL BIT BROKE, THE FRAGMENT WAS IMMEDIATELY REMOVED FROM THE PATIENT. 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 9386188 ↗
• MalfunctionNov 27, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE WIRE PASS DRILL BIT BROKE, THE FRAGMENT WAS IMMEDIATELY REMOVED FROM THE PATIENT. 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 9386186 ↗
• MalfunctionOct 22, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE BUR BROKE AT THE CUTTING END DURING A CRANIOTOMY PROCEDURE. 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 Consequences Or Impact To Patient

  MAUDE report 9220789 ↗