VariAx 53-27216SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540593887), received between Aug 20, 2015 and Jun 19, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2019Fracture; Material Deformation; Fracture; Material Deformation; Material Split, Cut or Torn

  TWO SCREWS ARE SPLIT IN SURGERY, A PORTION REMAINS INSIDE THE BONE. THE SCREWS ARE PLACED UNDER NORMAL CIRCUMSTANCES AND APPROPRIATE STEPS. NO ADVERSE CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8714865 ↗
• MalfunctionJun 19, 2019Fracture; Material Deformation; Fracture; Material Deformation; Material Split, Cut or Torn

  TWO SCREWS ARE SPLIT IN SURGERY, A PORTION REMAINS INSIDE THE BONE. THE SCREWS ARE PLACED UNDER NORMAL CIRCUMSTANCES AND APPROPRIATE STEPS. NO ADVERSE CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8714864 ↗
• MalfunctionAug 20, 2015Break; Detachment of Device or Device Component

  THE SALES REP, REPORTED ON BEHALF OF THE CUSTOMER, THAT 2 VARIAX DISTAL RADIUS SCREWS BROKE DURING SURGERY. THE SALES REP HAS REPORTED THAT ONE SCREW BENT WHILE BEING SCREWED INTO THE PATIENTS WRIST AND THE OTHER SCREWS' HEAD SHEARED OFF. THE SALES REP REPORTED THAT THE SHAFT OF THE SCREW HAS BEEN LEFT IN THE PATIENT AS THE SURGEON DETERMINED THAT IT WOULD BE TOO DIFFICULT TO REMOVE. THERE ARE NO CURRENT PLANS TO EXTRACT THE SHAFT OF THE SCREW. THE SURGERY WAS COMPLETED BY USING 2 NEW SCREWS AND THERE WAS NO DELAY TO SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5019043 ↗