AXSOS 705019-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327093407), received between Apr 22, 2019 and Oct 5, 2020 — classified as 3 malfunctions.

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

• MalfunctionOct 5, 2020Fracture; Fracture

  AS REPORTED: "FRACTURE REPAIR OF THE LEFT FEMUR. THE TIP OF THE DRILL BROKE DURING THE OPERATION. THE BROKEN TIP REMAINED IN THE PATIENT'S BONE. THE PATIENT WAS YOUNG AND HAD GOOD BONE QUALITY."

  Patient problems: Foreign Body In Patient

  MAUDE report 10631920 ↗
• MalfunctionJul 16, 2020Fracture; Fracture

  AS REPORTED: "DURING THE ORIF FOR THE FEMUR, WHEN OTHER COMPANY NAIL WAS INSERTED, THE FIXATOR WAS DRILLED, AND THE TIP OF THE DRILL WAS BROKE AND REMAINED INSIDE THE PATIENT'S BODY. THE BROKEN TIP OF THE DRILL WAS REMAINED INSIDE THE PATIENT BODY WITH THE SURGEON'S JUDGEMENT AND THE OPERATION WAS COMPLETED."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10286395 ↗
• MalfunctionApr 22, 2019Break; Fracture; Difficult to Remove; Fracture

  IT WAS REPORTED THAT THE TEMPORARY PLATE FIXATOR PIN BROKEN DURING THE OPERATION. THE BROKEN TIP IS IN THE PATIENT'S BODY AND UNABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8537010 ↗