VariAx 656316SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327070699), received between Aug 4, 2021 and Feb 24, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Positioning Failure

  THE CUSTOMER REPORTED THAT "DURING OSTEOSYNTHESIS OF THE LEFT DISTAL RADIUS USING A VARIAX PLATE AND SCREWS ON A DISPLACED FRACTURE, THE SURGEON ENCOUNTERED DIFFICULTIES WHEN INSERTING A 2.7 MM DIAMETER, 16 MM LONG LOCKING SCREW. THE FIRST FOUR SCREWS WERE INSERTED WITHOUT ANY PROBLEMS, BUT ¿THE FIFTH SCREW DID NOT LOCK INTO THE PLATE'S THREAD AND SPUN FREELY.¿ FURTHERMORE, DESPITE MULTIPLE ATTEMPTS, IT WAS IMPOSSIBLE TO REMOVE. THE SURGEON DECIDED TO REMOVE THE PLATE AND SCREWS AND USE A NEW PLATE AND NEW SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431118 ↗
• MalfunctionFeb 17, 2026Positioning Failure

  AS REPORTED: "I DRILLED THROUGH THE TUBE, BUT THE SCREW DID NOT LOCK. THE LOCATION IS THE SECOND ROW FROM THE FARTHEST END. THE PLATE IS DR2 NARROW. THE HOLE WHERE THE SCREW FAILED TO ENGAGE WAS NOT USED. HOWEVER, THIS DID NOT AFFECT THE OVERALL FIXATION STRENGTH.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24372665 ↗
• MalfunctionNov 10, 2025Inaccurate Information; Inaccurate Information

  THE CUSTOMER REPORTED THAT : "AFTER OPENING A BOX OF 2.7 MM X 16 MM LOCKING SCREWS, REF 656316S LOT 1000604646, DURING THE PROCEDURE, THE SURGICAL NURSE REALIZED THAT THERE WAS ANOTHER REFERENCE IN THIS BOX: REF 656318S LOT 1000592985 2.7 MM X 18 MM LOCKING SCREWS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23518630 ↗
• InjurySep 4, 2024Biocompatibility; Biocompatibility

  THE FOLLOWING EMAIL WAS RECEIVED FROM A PATIENT: "I HAD SURGERY FOR A BROKEN WRIST ON (B)(6) 2022 LAST YEAR. I HAD AN ALLERGIC REACTION TO IT AND WOULD NOW LIKE TO HAVE IT TESTED TO FIND OUT EXACTLY WHAT I AM ALLERGIC TO. THE DERMATOLOGIST ASKED ME TO REQUEST AN 'INGREDIENT LIST' SO THAT THEY COULD KNOW WHICH SAMPLES TO USE FOR TESTING. THE ALLERGY WAS DISCOVERED ON (B)(6) 2023 THE PLATE AND SCREWS WERE REMOVED."

  Patient problems: Foreign Body Reaction

  MAUDE report 20141012 ↗
• MalfunctionAug 7, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "WHEN INSERTING THE ANGLE-STABLE SCREW INTO THE PLATE WITH MAXIMUM PRESSURE, WITH THE STRONG MAN UA, IT CRACKED, THE SCREWDRIVER SLIPPED AND A SCREW HEAD PART HUNG FROM ITS TIP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470523 ↗
• MalfunctionJul 28, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "THREE LOCKING SCREWS FAILED TO LOCK DURING SURGERY FOR DISTAL END OF THE LEFT RADIUS USING VARIAX DR. THE LOCKING SCREWS DID NOT LOCK ONTO THE PLATE AND SPUN WITHOUT FASTENING. ALL THREE SCREWS WERE REPLACED WITH NEW SCREWS. AFTER REPLACEMENT, THE PLATE COULD BE LOCKED USING NEW SCREWS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414081 ↗
• MalfunctionAug 4, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED: "LOCKING FAILURE OF THE THREE LOCKING SCREWS WERE CONFIRMED. THE SPARE SCREWS WERE INSERTED AND THE SURGERY WAS FINISHED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276629 ↗
• MalfunctionAug 4, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED: "LOCKING FAILURE OF THE THREE LOCKING SCREWS WERE CONFIRMED. THE SPARE SCREWS WERE INSERTED AND THE SURGERY WAS FINISHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276612 ↗