NA 5407-350-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327504057), received between May 7, 2022 and Feb 19, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PIECE OF THE DEVICE WAS MISSING DURING TESTING AT THE USER FACILITY. NO PATIENT INVOLVEMENT, DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390994 ↗
• MalfunctionFeb 4, 2026Detachment of Device or Device Component

  A COMPONENT WAS NOTED TO BE MISSING FROM THE DEVICE DURING TESTING AT THE MANUFACTURING FACILITY. NO PATIENT INVOLVEMENT, DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257117 ↗
• MalfunctionNov 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY A ROUTER BROKE OFF IN THE DRILL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597291 ↗
• MalfunctionNov 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT A BROKEN CUTTING ACCESSORY WAS STUCK IN THE MOTOR AFTER A PROCEDURE AT THE USER FACILITY. NO PATIENT INVOLVEMENT, DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581061 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414286 ↗
• MalfunctionJul 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PIECE OF BUR WAS STUCK IN THE DEVICE DURING SERVICE AT THE MANUFACTURER FACILITY. NO PATIENT INVOLVEMENT, DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22376803 ↗
• MalfunctionJun 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN BUR WAS FOUND INSIDE THE MOTOR. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347240 ↗
• MalfunctionJun 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A PIECE OF A BUR STUCK IN 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 22143798 ↗
• MalfunctionMay 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BUR PIECE WAS FOUND INSIDE THE MOTOR. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE; NO DELAY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975890 ↗
• MalfunctionMay 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BUR PIECE WAS FOUND INSIDE THE MOTOR. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE; NO DELAY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975820 ↗
• MalfunctionFeb 24, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21449678 ↗
• MalfunctionFeb 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN BUR WAS FOUND INSIDE THE DEVICE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE; NO DELAY OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343421 ↗
• MalfunctionAug 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PROBE BROKE AND THAT IT WAS DISCOVERED PRIOR TO A CASE AND OCCURRED DURING THE STERILIZATION PROCESS. THE THIN SILVER WIRE BROKE AT THE BASE. IT WAS KINKED FOR SEVERAL CYCLES AND THEN IT FINALLY BROKE OFF WHEN IT WAS BEING CLEANED. IT SHOULD BE NOTED THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT ON THIS RECORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20021235 ↗
• MalfunctionAug 14, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE DRILL BIT BROKE DURING REPROCESSING 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 19978880 ↗
• MalfunctionMay 9, 2024Fracture; Fracture

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE BIT BROKE OFF INSIDE THE DRILL DURING A CASE 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 19281070 ↗
• MalfunctionMar 4, 2024Fracture; Fracture

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THERE WAS A BROKEN BUR IN THE DEVICE 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 18832506 ↗
• MalfunctionSep 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT GREASE WAS LEAKING FROM 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 17773078 ↗
• MalfunctionSep 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT GREASE WAS LEAKING FROM 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 17773076 ↗
• MalfunctionDec 8, 2022Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE BUR BROKE OFF IN THE DRILL DURING A PROCEDURE. 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 15944770 ↗
• MalfunctionMay 7, 2022Fracture; Fracture

  A BROKEN CUTTING ACCESSORY WAS FOUND WITHIN THE DEVICE DURING EQUIPMENT TESTING CONDUCTED BY A SERVICE TECHNICIAN AT THE MANUFACTURER FACILITY. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14322526 ↗