ASNIS 604648SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540089847), received between Mar 21, 2019 and Mar 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2019Entrapment of Device; Fracture; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE ASNISS4.0 , AXSOS AND VARIAX FIBULA WAS REMOVED DUE TO BONE FUSION. WHEN THE ASNISS 4.0 CAME BEFORE THE CORTICAL BONE, THE SCREW DID NOT TURN AND DEFORMED AND IT BECAME IMPOSSIBLE TO REMOVE IT. THEREFORE, THE HEAD WAS CUT OFF AND IT SHAFT WAS REMOVED WITH HOSITAL'S DRILL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8441960 ↗