AXSOS 703542Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540693808), received between Dec 1, 2018 and Feb 2, 2024 — classified as 3 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. How this data works · Data updated Oct 13, 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 18632370 ↗
• MalfunctionNov 19, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "TIP OF DRILL BIT BROKE OFF IN THE INTRAMEDULLARY CANAL OF FEMUR."

  Patient problems: Foreign Body In Patient

  MAUDE report 15829989 ↗
• MalfunctionDec 1, 2018Break

  A DRILL BIT PART NUMBER 703542'S TIP BROKE OFF IN PATIENT¿LEFT LEG DURING AN AXSOS3 DISTAL FEMORAL CASE. NO LOT NUMBER WAS ABLE TO BE TAKEN OFF THE DRILL BIT AND NO PRODUCTS RETURNED PER HOSPITAL POLICY. PROCEDURE FINISHED AS PLANNED AND THERE WERE NO DELAYS IN THE SURGERY. ALL INFORMATION AVAILABLE TO ME IS INCLUDED IN THIS PI.

  Patient problems: Foreign Body In Patient

  MAUDE report 8122200 ↗