NA 5407100000Recalls & reported problems

Summary

The FDA's MAUDE database contains 396 adverse event reports that list this exact device (DI 07613327096378), received between Jul 24, 2018 and Feb 25, 2025 — classified as 396 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (357 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 396 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE MAIN BODY WAS MISSING FROM THE DEVICE DURING EQUIPMENT TESTING CONDUCTED BY A SERVICE TECHNICIAN AT THE MANUFACTURER FACILITY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461613 ↗
• MalfunctionJun 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT A RING CAME OFF THE DEVICE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571476 ↗
• MalfunctionJan 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN VISUALLY DETECTED THAT A COMPONENT WAS MISSING WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536317 ↗
• MalfunctionJan 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A CERAMIC BALL MISSING WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18429651 ↗
• MalfunctionDec 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT INTERNAL COMPONENTS FELL OUT OF THE DRILL DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18339313 ↗
• MalfunctionNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A COMPONENT WAS MISSING FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230743 ↗
• MalfunctionNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A COMPONENT WAS MISSING FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230742 ↗
• MalfunctionNov 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL HAS A BROKEN BUR STUCK INSIDE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133740 ↗
• MalfunctionAug 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT SMALL RINGS CAME OUT OF THE HANDPIECE AT THE USER FACILITY. NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.

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

  MAUDE report 17660463 ↗
• MalfunctionAug 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A METAL PIECE CAME OUT OF THE HANDPIECE. NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.

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

  MAUDE report 17624926 ↗
• MalfunctionAug 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT TWO PIECES OF METAL COME OUT OF THE DRILL DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453560 ↗
• MalfunctionApr 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE DISASSEMBLED DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732961 ↗
• MalfunctionFeb 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS MISSING THE ENTIRE HOUSING AND MOTOR WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456465 ↗
• MalfunctionFeb 2, 2023Fracture; Fracture

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS RECEIVED WITH A SEGMENT OF A BUR STILL ATTACHED WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287481 ↗
• MalfunctionDec 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT A SMALL PIECE OF THE DEVICE FELL OUT OF THE DRILL DURING SETUP AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16066862 ↗
• MalfunctionSep 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BUR RETENTION COMPONENTS. THE EVENT OCCURRED DURING FUNCTIONAL TESTING WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352437 ↗
• MalfunctionAug 5, 2022Flaked; Flaked

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT DURING A SURGICAL PROCEDURE, THE SURGEON SAW METAL FLAKES. IT WAS ALSO REPORTED THAT THE SURGEON IMMEDIATELY STOPPED USING THE DRILL. THE WOUND WAS IRRIGATED COPIOUSLY ANOTHER DRILL BIT WAS OPENED TO THE FIELD AND THE CASE CONTINUED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178710 ↗
• MalfunctionJun 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT AT THE END OF A PROCEDURE WHEN THE ROUTER WAS REMOVED FROM THE DRILL AND ATTACHMENT, THE ROUTER BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786568 ↗
• MalfunctionMay 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP BROKE. IT WAS FURTHER REPORTED THAT FLUOROSCOPY USED TO CONFIRM NO OTHER PIECES REMAINED. IT WAS ALSO REPORTED THAT THE EVENT CAUSED A TWO MINUTE DELAY TO THE PROCEDURE. IT WAS ALSO REPORTED THERE WERE 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 14524488 ↗
• MalfunctionApr 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING OIL DURING TESTING. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193072 ↗
• MalfunctionMar 23, 2022Fracture; Fracture

  IT WAS REPORTED THERE WAS A BROKEN BUR WITHIN THE DEVICE DURING TESTING AT THE MANUFACTURER FACILITY. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13863048 ↗
• MalfunctionNov 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT AFTER A PROCEDURE AT THE USER FACILITY THE HANDPIECE HAD A BUR BROKEN OFF INSIDE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12803929 ↗
• MalfunctionSep 16, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE BALL COLLAR ON THE DEVICE WAS MISSING BY THE MANUFACTURER SERVICE TECHNICIAN. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481596 ↗
• MalfunctionJul 30, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING BLACK FLUID. 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 12254775 ↗
• MalfunctionJul 22, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS GETTING HOT DURING TESTING AT THE USER FACILITY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211216 ↗