NA 03.130.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982075345), received between Feb 6, 2025 and Mar 26, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Failure to Cut

  DURING SURGERY, THE SURGEON COMPLAINED THAT THE DRILL BITS WERE DULL AND WERE NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY. THESE COMPONENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. IN ADDITION, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE TIPS OF THE SCREWDRIVER SHAFTS WERE BENT AND SLIGHTLY DEFORMED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698279 ↗
• MalfunctionMar 26, 2026Failure to Cut

  DURING SURGERY, THE SURGEON COMPLAINED THAT THE DRILL BITS WERE DULL AND WERE NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY. THESE COMPONENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. IN ADDITION, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE TIPS OF THE SCREWDRIVER SHAFTS WERE BENT AND SLIGHTLY DEFORMED. THESE ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698274 ↗
• MalfunctionMar 18, 2026Failure to Cut

  DURING SURGERY, IT WAS NOTED THAT THE IDENTIFIED DRILL BITS LISTED IN THIS COMPLAINT WERE DULL AND WERE NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY. THESE COMPONENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. REPLACEMENTS ARE REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627487 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE DRILL BIT WAS BEING DRILLED, THE 1.1-INCH DRILL BIT OF THE 1.5-INCH SYSTEM BROKE. THIS PROBLEM WAS RESOLVED BY REMOVING THE DRILL BIT ALONG WITH ITS FRAGMENTS. ANOTHER DRILL BIT WITH THE SAME CHARACTERISTICS, ALSO INCLUDED WITH THE EQUIPMENT, WAS PASSED TO THE DOCTOR, THUS SUCCESSFULLY COMPLETING THE SURGERY. THIS RESULTED IN NO DISCOMFORT FOR THE SPECIALIST, NO HARM TO THE PATIENT, AND NO ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829615 ↗
• MalfunctionApr 2, 2025Break; Entrapment of Device; Break; Entrapment of Device

  DURING THE PROCEDURE, WHILE DRILLING, THE 1.1 DRILL BIT BROKE, LEAVING THE TIP OF THIS DRILL BIT INSIDE THE PATIENT'S BONE. AN ATTEMPT WAS MADE, BUT IT WAS NOT POSSIBLE TO REMOVE THIS FRAGMENT OF THE DRILL BIT THAT BROKE, AND THE DOCTOR DECIDED TO LEAVE THE TIP INSIDE THE BONE AND LOOK FOR A NEW HOLE TO DRILL WITH A NEW 1.1 DRILL BIT THAT ALSO CAME WITH THE EQUIPMENT, THUS SUCCESSFULLY COMPLETING THE SURGERY. THERE WAS NO SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21755565 ↗
• MalfunctionFeb 6, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO BROKEN FRAGMENTS RETAINED IN THE PATIENT AND NO DRILL BIT WAS REMOVED BEFORE SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21323030 ↗