AXSOS 702707Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154092666), received between Sep 9, 2015 and Dec 13, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2019Fracture; Fracture

  THE CUSTOMER REPORTED THAT AN AXSOS LOCKING DRILL GUIDE SNAPPED AND THAT THIS WAS DUE TO A USER ERROR. ADDITIONALLY REPORTED: THE SURGEON REPORTED THAT HE HAD USED THE GUIDE AS A HANDLE TO PASS THE PLATE THROUGH A SMALLER INCISION AND IT WAS AT THIS POINT IT HAD BROKEN. HE STATED HE HAS USED THIS METHOD WITH OTHER KITS IN THE PAST. NO METAL FELL INTO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9468131 ↗
• MalfunctionSep 9, 2015Break

  DURING A HUMERUS FRACTURE PROCEDURE, THE SURGEON PLACED THE INSTRUMENT ON THE PLATE TO HELP WHEN SETTING THE SCREW. WHEN PERFORMING THE TORQUE THE INSTRUMENT WAS DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5065587 ↗