VARIAX 656446Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327462395), received between Sep 22, 2021 and Sep 22, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionSep 22, 2021Fracture; Fracture

  IT WAS REPORTED THE SURGEON WAS USING THE VARIAX MINI FRAGMENT TO REPAIR AN ANKLE FRACTURE. THE SURGEON USE A 10 HOLE 2.7MM BROAD PLATE AND BEGAN TO POPULATE THE PLATE USING THE T8 2.7MM SCREWS. THE SURGEON WENT TO DO A 2.7MM SYNDESMOTIC SCREW THROUGH THE PLATE, THE FIBULA, AND THE TIBIA. HE DRILLED A 2.0MM PILOT HOLE AND MEASURED A 2.7X46MM SCREW. HE INSERTED THE SCREW ON POWER AND THEN SWITCH TO THE SMALL, BLUE, ASNIS MICRO SCREWDRIVER HANDLE. AS HE FINAL SEATED THE SCREW THE SCREW HEAD SHEARED OFF THE SHAFT OF THE SCREW. THE SCREW HEAD WAS RETREIVED, BUT THE SHAFT REMAINED EMBEDDED IN THE BONE. THE SURGEON USED A DIFFERENT SCREW TO FINISH THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512754 ↗