VARIAX 705134Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327398922), received between Feb 17, 2020 and Aug 27, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "IT WAS REPORTED THAT 2.0 STRYKER VARIAX DRILL BIT BROKE OFF IN PATIENT'S TIBIA. UNABLE TO RETRIEVE BROKEN BIT FROM PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 22908832 ↗
• InjuryOct 18, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT "A MEDICAL DEVICE INCIDENT (MDI) WITH HARM HAS BEEN REPORTED. STRYKER VARIAX 2.0 DRILL BIT BROKE OFF IN PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 20487176 ↗
• MalfunctionNov 16, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT WITH A CLOSED TRIMALLEOLAR ANKLE FRACTURE SCHEDULED FOR OPEN REDUCTION INTERNAL FIXATION. DURING THE OPERATIVE PROCEDURE, ONE OF THE 2.0 MM DRILL BITS BROKE AND WAS LODGED IN THE TIBIA. DUE TO THE LOCATION OF THE DRILL BIT, IT WAS DETERMINED REMOVAL WOULD RESULT IN FURTHER DAMAGE TO THE BONE AND THE BIT WAS LEFT IN THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 15805478 ↗
• MalfunctionFeb 17, 2020Fracture; Fracture

  AS REPORTED: "DRILL TIP BROKE OFF WHILE DRILLING 5TH OUT OF 6 HOLES, VARIAX 2 SCREW HEAD CAME OFF WHEN FINAL TIGHTENING INTO PLATE, AND AXSOS SCREW HEAD BROKE WHILE IMPLANTING." REP REPORTED THAT THE PROCEDURE WAS A REVISION DUE TO "NONUNION OF DISTAL FEMUR FRACTURE." WITH COMPLICATING CONDITION "ABOVE IMPLANT FEMUR SHAFT FRACTURE ALONG WITH NONUNION."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9718532 ↗