NA 702449Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540112033), received between Nov 19, 2018 and Mar 25, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Residue After Decontamination

  AS REPORTED: "WHEN USING THE CANULATED DRILL, IT DID NOT GO THROUGH THE K-WIRE, AND WHEN THE CANULATION WAS CHECKED, SOMETHING LIKE DEBRIS CAME OUT FROM INSIDE. THE CANULATION WAS THOROUGHLY CLEANED AND THE DRILL WAS USED AS IS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688797 ↗
• InjuryDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, THE DRILL BROKE DURING USE LEAVING FRAGMENTS INSIDE THE BODY. IN ADDITION TO THE DRILL, THE GUIDE WIRE ALSO BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23817134 ↗
• MalfunctionNov 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE DRILL BROKE OFF DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462639 ↗
• MalfunctionSep 24, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE DRILL BIT BROKE IN TWO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137842 ↗
• MalfunctionMay 14, 2021Break; Break

  AS REPORTED: "THE VIEW IS THAT A BROKEN HOLLOW DRILL IN THE ECCENTRICITY OF THE GUIDE PIN IS A TECHNICAL ERROR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824308 ↗
• MalfunctionMar 4, 2020Break; Fracture; Break; Fracture

  AS REPORTED: "THE ORIF PROCEDURE WAS PERFORMED USING AZNIS 4.0. DURING DRILLING, THE TIP OF THE DRILL [...] WAS BROKEN. THERE ARE NO RESIDUES LEFT IN THE PATIENT¿S BODY. THE PROCEDURE WAS CONTINUED USING AZNIS III 5.0 AND WAS COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788155 ↗
• MalfunctionNov 19, 2018Break; Entrapment of Device

  THE CUSTOMER REPORTED THAT THE CANNULATED DRILL IS STUCK INSIDE THE DRILL GUIDE. THE DRILL SNAPPED AS THE SURGEON WAS TRYING TO GET IT OUR OF THE GUIDE. NO PIECES FELL INTO THE PATIENT. 5 MINS SURGICAL DELAY WHILE A NEW SET WAS OPENED. NO ADVERSE CONSEQUENCES.

  Patient problems: No Code Available

  MAUDE report 8084081 ↗