VariAx 656416Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327068856), received between Dec 13, 2018 and Mar 12, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SCREW HEAD SNAPPED OFF WHILE BEING INSERTED INTO THE OBLONG HOLE OF AN XXL PLATE, LEAVING THE SCREW SHAFT EMBEDDED WHILE THE HEAD REMAINED ON THE DRIVER. THE PROCEDURE WAS DELAYED BY 10 MINUTES AS THE TEAM ASSESSED HOW TO MANAGE THE BROKEN SCREW AND ITS POTENTIAL IMPACT ON THE PATIENT. ULTIMATELY, THE BROKEN SCREW SHAFT WAS LEFT IN THE PATIENT, AND THE HOLE COULD NOT BE USED DUE TO THE SCREW FAILURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21587926 ↗
• InjuryNov 19, 2021Break; Fracture; Break; Fracture

  CUSTOMER REPORTED THE FOLLOWING ISSUE: "THE OPERATING ROOM REPORTED AN INCIDENT ON (B)(6) 2021 WITH 2 CORTICAL SCREWS REFERENCE 656416. THE 2 SCREWS BROKE BEFORE REACHING THE END OF THEIR TRAVEL. IT WAS NECESSARY TO CORE DRILL TO EXTRACT THEM." ***ADDITIONAL INFORMATION RECEIVED - (B)(6) 2021: SURGICAL DELAY (APPROX. 20 MIN) AND NEED FOR CORING TO REMOVE BROKEN SCREWS. ADVERSE IMPACT ON PATIENT: BONE FRACTURE AT THE CORING SITE

  Patient problems: Bone Fracture(s)

  MAUDE report 12844626 ↗
• InjuryNov 19, 2021Break; Fracture; Break; Fracture

  CUSTOMER REPORTED THE FOLLOWING ISSUE: "THE OPERATING ROOM REPORTED AN INCIDENT ON (B)(6) 2021 WITH 2 CORTICAL SCREWS REFERENCE 656416. THE 2 SCREWS BROKE BEFORE REACHING THE END OF THEIR TRAVEL. IT WAS NECESSARY TO CORE DRILL TO EXTRACT THEM." ***ADDITIONAL INFORMATION RECEIVED - (B)(6)2021: SURGICAL DELAY (APPROX. 20 MIN) AND NEED FOR CORING TO REMOVE BROKEN SCREWS. ADVERSE IMPACT ON PATIENT: BONE FRACTURE AT THE CORING SITE

  Patient problems: Bone Fracture(s)

  MAUDE report 12844489 ↗
• MalfunctionAug 25, 2021Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  AS REPORTED: "THE SURGEONS WERE PERFORMING AN OPEN REDUCTION PROCEDURE OF THE RIGHT DISTAL RADIO WHICH THE DORSAL PART WAS SOMETHING COMMINUTE, A RIGHT EXTRACTOR PLATE IS PLACED. DISTAL RADIO 49MM REFERENCE 5425683 LOT 1000428950 THE OVAL HOLE OF THE BRANCH IS FIXED TO THE DISTAL PART OF THE PLATE WITH A CORTICAL SCREW OF 2.7X 16MM VERIFYING WITH X-RAYS AND THEN FIXING THE DISTAL PART USING THE 2.0MM LOCKING GUIDE HOLES WHICH DO NOT BLOCK, SEVERAL DRILLINGS ARE MADE IN DIFFERENT HOLES BUT THE SAME HAPPENED WITHOUT BLOCKING THE SCREWS, WHICH HAD BEEN USED 2.4MM X 18MM, 20MM, 22MM BLOCK T. AND THEN THE LAST BRANCH OF THE DISTAL HOLE IS FIXED PROXIMAL PART OF THE PLATE WITH A 2.7X14MM CORTICAL SCREWS, IT IS DECIDED TO REMOVE THE PLATE TO VERIFY THE DIRECTION OF THE HOLES AND THEIR LOCKING FUNCTION, SMART LOOK SYSTEM, BUT THEY DO NOT BLOCK THE ORIFICES AND THEY ARE MADE WITH A NEW SCREWS. THE SURGEON WAS ANGRY BY SUCH EVENT WHICH DECIDES NOT TO USE THE DISTAL RADIO SYSTEM WITH THE USED PLATE ANY MORE AND TO FIX THE H, DISTAL RADIO OF L APTE WITH KIRSCHNER NAILS 1.25 AND 1.1MM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365812 ↗
• MalfunctionJun 2, 2021Positioning Failure; Positioning Failure

  AS REPORTED: "INCIDENT THAT HAS OCCURRED ON 5 OCCASIONS IN THE TRAUMATOLOGICAL HOSPITAL CORRESPONDING TO THE SURGERIES THAT WE HAVE TENDERED WITH THE RADIO DISTAL VARIAX PLATETHE SPECIFIC PROBLEM IS THAT WHEN THE SCREW 2.7 IS PLACED IN THE OVAL HOLE OF THE PLATE, IT ROLLS, DOES NOT TIGHTEN, IT BECOMES LOOSE, ALTHOUGH THE LENGTH OF THE SCREW HAS BEEN CHANGED SEVERAL TIMES.THE SCREW BOX WAS REVIEWED BY CHECKING THE SCREW HEAD, CHANGING THE SCREWDRIVER, TALKING AND OBSERVING WITH THE ASSISTANTS AND DOCTORS ABOUT THE TECHNIQUE USED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926343 ↗
• MalfunctionSep 18, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "ANGULAR STABILITY IS FUNCTIONLESS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10557198 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VARIAX FOOT PLATE METALLOSIS NOTICED UPON REMOVAL ON (B)(6) 2019 BY SURGEON. IMPLANTED ON (B)(6) 2019. REMOVAL NOT FOR NON-UNION, JUST REMOVAL OF METALWARE.

  Patient problems: Injury; Reaction

  MAUDE report 9549412 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT MIDFOOT OPEN REDUCTION + INTERNAL FIXATION + LISFRANC STABILISATION. METALLOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Injury; Reaction

  MAUDE report 9549276 ↗
• MalfunctionDec 13, 2018Break

  PRIMARY PROCEDURE, LEFT DISTAL RADIUS. IT WAS REPORTED THAT A 2.7 X 16 BONE SCREW BROKE AT THE HEAD DURING INSERTION. THE HEAD WAS REMOVED, THE PORTION IN THE PATIENT'S BONE WAS LEFT IN AND ANOTHER SCREW HOLE WAS USED TO COMPLETE THE PROCEDURE WITH A SURGICAL DELAY OF LESS THAN 1 MINUTE REPORTED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8162198 ↗