VARIAX 62-17333Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540540935), received between Jan 24, 2019 and May 26, 2021 — classified as 2 malfunctions.

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

• MalfunctionMay 26, 2021Component Missing; Component Missing

  IT HAS BEEN REPORTED THAT WHEN OPENING THE VARIAX HAND KIT NUMBER PLATE TVARXM28 / IVARXM28 IN THE OPERATING ROOM, WITH THE PATIENT ANESTHETIZED, THEY NOTICED THAT THE TWO SCREWDRIVER BLADES (REF:62-17333 AND 62-23333) WERE MISSING FROM THE KIT. FACED WITH THE IMPOSSIBILITY OF PLACING THE PLATE AND SCREWS, THE OPERATING SURGEON WAS FORCED TO SYNTHESIZE THE FRACTURE USING KIRSCHNER WIRES AND SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11889375 ↗
• MalfunctionJan 24, 2019Mechanical Jam

  THE CUSTOMER REPORTED THAT AS THE SURGEON WAS IMPLANTING A SCREW INTO THE FINGER OF A MALE PATIENT, THE SCREW GOT STUCK IN THE SCREWDRIVER. THE SURGEON TRIED TO TOGGLE THE SCREWDRIVER TO RELEASE THE SCREW BUT THIS ACTION PULLED THE SCREW OUT FROM THE BONE. THE PATIENT HAD OSTEOPOROSIS. THE CASE WAS COMPLETED SUCCESSFULLY AS THERE WERE OTHER HOLES IN THE PLATE WHICH COULD BE USED. THERE WERE NO DELAYS TO SURGERY. THE CUSTOMER REPORTED THAT THIS SCREWDRIVER HAS LIKELY BEEN ON THE SET FOR NEARLY 10 YEARS AND IS LIKELY TO BE WORN. THE SCREWDRIVER HAS BEEN QUARANTINED FROM USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276292 ↗