VariAx 657016Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327069297), received between Dec 22, 2020 and Aug 22, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "DURING SURGERY TODAY, THE DOCTOR DECIDED TO PLACE A LATERAL FIBULA PLATE. THE PROCEDURE STARTED WITH THE PLACEMENT OF THE MOST DISTAL SCREWS. THE DOCTOR CHOSE TO USE 2.7 MM LOCKING SCREWS, SO THE ASSISTANT PROVIDED THE 2.0 MM DRILL AND THE CORRESPONDING GUIDE. WHEN ATTEMPTING TO PLACE THE SCREWS, NONE OF THE THREE LOCKED. THE ASSISTANT SUGGESTED THAT THE DOCTOR ORIENT THE SCREWS IN A DIFFERENT DIRECTION. WITH THIS ADJUSTMENT, TWO OF THE SCREWS SUCCESSFULLY LOCKED, BUT THE THIRD ONE DID NOT LOCK IN ANY DIRECTION THE DOCTOR TRIED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030954 ↗
• MalfunctionAug 27, 2021Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT A PACKAGE OF LOCKING VARIAAX 2 SCREWS (657016) CONTAINED NON-LOCKING SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377599 ↗
• MalfunctionAug 27, 2021Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT A PACKAGE OF LOCKING VARIAAX 2 SCREWS (657016) CONTAINED NON-LOCKING SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377566 ↗
• MalfunctionApr 15, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "SURGEON WAS USING THE VARIAX 2 SMALL FRAG AND VARIAX 2 CORE TRAY FOR AN ANKLE FRACTURE. THE SURGEON USED PROPER TECHNIQUE IN REGARDS TO USING THE DRILL SLEEVE AND STAYED WITHIN THE 30 DEGREE CONE THAT THE 40-20905 FIBULA PLATE WARRANTS. UPON INSERTING A 657016 LOCKING SCREW, IT DID NOT ENGAGE THE LOCKING MECHANISM. THE SURGEON REMOVED THE SCREW AND USED A FRESH/ NEW 657016 SCREW IN THE SAME SCREW HOLE AND THE SCREW ENGAGED THE PLATE AND LOCKING WAS SUCCESSFUL. LATER ON IN THE CASE, HE ATTEMPTED TO ENGAGE (3) 657312 LOCKING SCREWS INTO THE SAME 40-20905 PLATE WITH THE SAME APPROPRIATE TECHNIQUE AND THOSE SCREWS ALSO DID NOT ENGAGE/LOCK INTO THE PLATE SUCCESSFULLY AND THERE WAS ALSO METAL SHAVINGS THAT APPEARED AFTER THE REMOVAL OF THE SCREWS. THE METAL SHAVINGS ARE NOT KNOWN IF THEY CAME FROM THE SCREWS OR THE FIBULA PLATE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670086 ↗
• MalfunctionDec 22, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "NO BLOCKING WAS POSSIBLE - THE PLATE HAD TO BE REMOVED. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 15MIN. NOT LONGER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11060312 ↗