AXSOS 705020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327091663), received between Sep 18, 2015 and Dec 28, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2020Fracture; Fracture

  AS REPORTED: "SURGEON ATTEMPTED TO REMOVE A LOCKING SCREW WITH MANUAL SCREWDRIVER FROM AXSOS DISTAL FEMUR PLATE. THE TIP OF THE SCREWDRIVER BROKE OFF IN THE PATIENT FROM EXCESSIVE FORCE. A SMALL FRAGMENT OF THE SCREWDRIVER HAD TO BE LEFT IN THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 11077166 ↗
• MalfunctionSep 18, 2015Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER WAS BROKEN WITH TORQUE LIMITER. A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. EVENT OCCURRED DURING A PRIMARY SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5088807 ↗