VariAx 53-27214SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540593870), received between Sep 18, 2015 and Nov 14, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN 2018, THE CLAIMANT HAD AN ORIF AND WAS IMPLANTED WITH UNKNOWN PINS AND A PLATE, AROUND (B)(6) 2021/(B)(6) 2022, SHE FELT SOME DISCOMFORT/IRRITATION AND SOUGHT MEDICAL CARE. THE REVISION WAS SCHEDULED FOR (B)(6) 2022 TO REMOVE THE IMPLANTED DEVICES. DURING THE SURGERY, THE SURGEON DISCOVERED THAT HE DID NOT HAVE THE CORRECT INSTRUMENTS TO REMOVE THE HARDWARE. THE HOSPITAL SPENT SOME TIME TRYING TO FIND A SUITABLE TO ASSIST IN THE REMOVAL, BUT COULD NOT LOCATE A SUITABLE SCREWDRIVER. HOWEVER, ONE SCREW WAS ABLE TO BE REMOVED THROUGH CAREFUL USE OF A SMALLER SCREWDRIVER HEAD. SINCE THE FAILED SURGERY, THE PATIENT HAS BEEN LEFT WITH A RAISED RED RASH ON HER WRIST, AND IS IN MORE PAIN THAN BEFORE THE FAILED SURGERY. ADDITIONALLY, THIS IS AFFECTING HER WRIST MOVEMENT MORE THAT BEFORE THE SURGERY.

  Patient problems: Implant Pain; Loss of Range of Motion; Skin Inflammation/ Irritation

  MAUDE report 18132908 ↗
• MalfunctionMar 29, 2018Difficult to Insert

  THE SURGEON REPORTED THAT WHEN IMPLANTING A DISTAL RADIUS PLATE, TWO 2.7MM SCREWS WERE TWISTING IN THE HOLE AND NOT GETTING PURCHASE. THE CASE WAS COMPLETED USING 2 NEW 2.3MM SCREWS AND BY DRILLING 2 NEW HOLES ALONG THE OBLONG. THE PATIENT WAS YOUNG AND WITH GOOD BONE. THERE WAS A SHORT DELAY OF A FEW MINUTES WHILE ADDITIONAL HOLES WERE DRILLED AND NEW SCREWS WERE OBTAINED. THE SURGEON WAS SATISFIED WITH THE OUTCOME OF THE CASE.

  Patient problems: No Information

  MAUDE report 7383027 ↗
• MalfunctionMar 29, 2018Difficult to Insert; Material Twisted/Bent

  THE SURGEON REPORTED THAT WHEN IMPLANTING A DISTAL RADIUS PLATE, TWO 2.7MM SCREWS WERE TWISTING IN THE HOLE AND NOT GETTING PURCHASE. THE CASE WAS COMPLETED USING 2 NEW 2.3MM SCREWS AND BY DRILLING 2 NEW HOLES ALONG THE OBLONG. THE PATIENT WAS YOUNG AND WITH GOOD BONE. THERE WAS A SHORT DELAY OF A FEW MINUTES WHILE ADDITIONAL HOLES WERE DRILLED AND NEW SCREWS WERE OBTAINED. THE SURGEON WAS SATISFIED WITH THE OUTCOME OF THE CASE.

  Patient problems: No Code Available

  MAUDE report 7383022 ↗
• MalfunctionSep 18, 2015Break

  DURING VARIAX DR SURGERY, THE SURGEON DRILLED SCREW HOLE WITH A 2.0MM DRILL BIT. THE SURGEON INSERTED THE CORTICAL SCREW INTO THE PLATE SCREW HOLE. HOWEVER, THE SHAFT OF CORTICAL SCREW BROKE. THE SURGEON REMOVED THE BROKEN SCREW. THE SURGEON DRILLED ANOTHER SCREW HOLE WITH A 2.3MM DRILL BIT. THE SURGEON INSERTED THE LOCKING SCREW IN ANOTHER SCREW HOLE. THE SHAFT OF SCREW BROKE AGAIN. THE SURGEON WAS NOT ABLE TO REMOVE THE SHAFT OF BROKEN SCREW. THE SURGEON IS REQUESTING AN IMMEDIATE INVESTIGATION OF THE BROKEN SCREWS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5088814 ↗
• MalfunctionSep 18, 2015Break

  DURING VARIAX DR SURGERY, THE SURGEON DRILLED SCREW HOLE WITH A 2.0MM DRILL BIT. THE SURGEON INSERTED THE CORTICAL SCREW INTO THE PLATE SCREW HOLE. HOWEVER, THE SHAFT OF CORTICAL SCREW BROKE. THE SURGEON REMOVED THE BROKEN SCREW. THE SURGEON DRILLED ANOTHER SCREW HOLE WITH A 2.3MM DRILL BIT. THE SURGEON INSERTED THE LOCKING SCREW IN ANOTHER SCREW HOLE. THE SHAFT OF SCREW BROKE AGAIN. THE SURGEON WAS NOT ABLE TO REMOVE THE SHAFT OF BROKEN SCREW. THE SURGEON IS REQUESTING AN IMMEDIATE INVESTIGATION OF THE BROKEN SCREWS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5088774 ↗