VARIAX 657320Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327086928), received between Jul 21, 2020 and Sep 15, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AS THE SCREW PROGRESSED, IT WOULD NOT ENGAGE THE LOCKING MECHANISM. IT WAS FURTHER REPORTED THAT IT SPUN FREELY LOSING ALL COMPRESSION ON THE BONE. A SURGICAL DELAY OF 45-MINUTES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15433325 ↗
• MalfunctionJul 28, 2020Positioning Failure; Positioning Failure

  ACCORDING TO THE SURGEON, THE CUSTOMER HAD LOCKING PROBLEMS WHEN USING THE T10 3.5MM VARIAX 2 LOCKING SCREWS IN THE DISTAL HOLES OF THE VARIAX PLATES, DISTAL HUMERUS (ULNAR AND RADIAL) AND DISTAL RADIUS. THE SCREWS HAVE NOT LOCKED AT A STABLE ANGLE. BONE SCREWS WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY. SURGICAL DELAY OF 5MIN. NOT LONGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10334388 ↗
• MalfunctionJul 28, 2020Positioning Failure; Positioning Failure

  ACCORDING TO THE SURGEON, THE CUSTOMER HAD LOCKING PROBLEMS WHEN USING THE T10 3.5MM VARIAX 2 LOCKING SCREWS IN THE DISTAL HOLES OF THE VARIAX PLATES, DISTAL HUMERUS (ULNAR AND RADIAL) AND DISTAL RADIUS. THE SCREWS HAVE NOT LOCKED AT A STABLE ANGLE. BONE SCREWS WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY. SURGICAL DELAY OF 5MIN. NOT LONGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10334374 ↗
• MalfunctionJul 28, 2020Positioning Failure; Positioning Failure

  ACCORDING TO THE SURGEON, THE CUSTOMER HAD LOCKING PROBLEMS WHEN USING THE T10 3.5MM VARIAX 2 LOCKING SCREWS IN THE DISTAL HOLES OF THE VARIAX PLATES, DISTAL HUMERUS (ULNAR AND RADIAL) AND DISTAL RADIUS. THE SCREWS HAVE NOT LOCKED AT A STABLE ANGLE. BONE SCREWS WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY. SURGICAL DELAY OF 5MIN. NOT LONGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10334365 ↗
• MalfunctionJul 28, 2020Positioning Failure; Positioning Failure

  ACCORDING TO THE SURGEON, THE CUSTOMER HAD LOCKING PROBLEMS WHEN USING THE T10 3.5MM VARIAX 2 LOCKING SCREWS IN THE DISTAL HOLES OF THE VARIAX PLATES, DISTAL HUMERUS (ULNAR AND RADIAL) AND DISTAL RADIUS. THE SCREWS HAVE NOT LOCKED AT A STABLE ANGLE. BONE SCREWS WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY. SURGICAL DELAY OF 5MIN. NOT LONGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10334364 ↗
• MalfunctionJul 21, 2020Positioning Failure; Positioning Failure

  ACCORDING TO THE SURGEON, THE CUSTOMER HAD LOCKING PROBLEMS WHEN USING THE T10 3.5MM VARIAX 2 LOCKING SCREWS IN THE DISTAL HOLES OF THE VARIAX PLATES, DISTAL HUMERUS (ULNAR AND RADIAL) AND DISTAL RADIUS. THE SCREWS HAVE NOT LOCKED AT A STABLE ANGLE. BONE SCREWS WERE USED TO COMPLETE THE SURGERY SUCCESSFULLY. SURGICAL DELAY OF 5MIN. NOT LONGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10305724 ↗