AXSOS 703541Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540693792), received between Sep 2, 2020 and Feb 2, 2024 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionFeb 2, 2024Break; Fracture; Break; Fracture

  CUSTOMER REPORT: "THE STAFF IN TRAUMA THIS AFTERNOON HAVE REPORTED TO ME THAT 2, 3.2MM DRILLS HAVE JUST BROKEN DURING A DISTAL FEMORAL PLATING, ONE BEING LEFT IN THE PATIENT AS THEY ARE UNABLE TO REMOVE IT."

  Patient problems: Foreign Body In Patient

  MAUDE report 18635025 ↗
• InjuryMay 17, 2021Fracture; Fracture

  IT WAS REPORTED THE 4.3 MM DRILL BROKE; THE BROKEN DRILL TIP WAS REMOVED BY AN ARTHROSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11835107 ↗
• MalfunctionSep 2, 2020Fracture; Fracture

  AS REPORTED: "TIP OF AXSOS3 4.3MM DRILL (ITEM NO. 703541) BROKE OFF INSIDE LEFT DISTAL FEMUR WHILST DRILLING THE BONE IN PREPARATION FOR SCREW INSERTION. APPROXIMATELY 10MM OF 4.3MM DRILL BIT RETAINED. POSITION OF BROKEN DRILL TIP INSIDE BONE CONFIRMED BY X-RAY. PATIENT INFORMED POST OP."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10485732 ↗