VARIAX 62-27015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540594150), received between Jul 30, 2018 and Mar 13, 2020 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2020Fracture; Fracture

  AS REPORTED: "THE SCREW COULD NOT BE INSERTED. THE TIP MAY BE DEFORMED." DEVICE IMAGE SHOWED TIP FRACTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9829866 ↗
• MalfunctionFeb 21, 2019Fitting Problem

  CUSTOMER REPORTED THAT THE CASE WAS ABANDONED AFTER THE PATIENT HAD BEEN ANESTHETISED BECAUSE THE APPROPRIATE TOOLS WERE NOT AVAILABLE. THE T7 BLADE DID NOT FIT INTO THE ANCHORAGE SCREWDRIVER OR OTHER HANDLES THAT WERE IN THE THEATRE. THE BLADE WAS DROPPED AND THE SURGEON NO LONGER FELT COMFORTABLE TO CONTINUE THE SURGERY WITHOUT THE CORRECT SCREWDRIVER AND THE PATIENT WAS SENT BACK TO THE WARD. ALSO, THE SCREWS PRESENT IN SURGERY WERE CROSS HEAD SCREWS AND NOT THE T7 SCREWS BECAUSE THE CUSTOMER WAS MISINFORMED OF THE PRODUCTS. THE VARIAX DISTAL RADIUS PLATE HAS BEEN REMOVED ON THE SAME DAY IN AFTERNOON UPON SECOND ATTEMPT. THE REASON FOR REMOVAL IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8359257 ↗
• MalfunctionJul 30, 2018Break; Entrapment of Device

  DURING SURGERY THE TIP OF SCREWDRIVER BREAK OFF AND REMAIN STUCK IN THE SCREW INTERFACE. WHEN THE PLATE NEED TO BE REMOVED LATER IT WILL BE DIFFICULT DUE TO THE FACT THAT THE SCREW INTERFACE IS BLOCKED BY THE BROKEN TIP OF SCREWDRIVER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732847 ↗