AXSOS 703792Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540694218), received between Jul 16, 2021 and Jul 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2021Device Contamination with Body Fluid; Device Contamination with Body Fluid

  AS REPORTED: "WE WERE USING AN AXSOS3 DISTAL FEMUR PLATE FOR A PERIPROSTHETIC FRACTURE USING THE CONSIGNED TARGETING INSTRUMENT SET. THE PLATE WAS INSERTED INTO THE PATIENT ROUGHLY 20-30 MINUTES AFTER THE FIRST INCISION, ATTACHED TO THE TARGETING INSTRUMENTS. AS THE SURGEON/REGISTRAR ATTEMPTED TO INSERT THE FIRST LOCKING SCREW DISTALLY USING A TISSUE SLEEVE AND LOCKING DRILL SLEEVE, THEY NOTICED THAT THE SLEEVE WAS CONTAMINATED WITH WHAT WAS BELIEVED TO BE BLOOD FROM A PREVIOUS CASE AFTER PUSHING THE LOCKING DRILL BIT THROUGH THE DRILL SLEEVE AND PULLING IT BACK OUT (THEY HADN¿T DRILLED INTO THE PATIENT AT THIS STAGE). THEY DECIDED TO PUSH AHEAD WITH THE CASE, THEY PUT THE CONTAMINATED DRILL SLEEVE AND DRILL BIT TO THE SIDE AND CARRIED ON USING THE REST OF THE CLEAN INSTRUMENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183559 ↗