AXSOS 705002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327086157), received between Mar 29, 2019 and Dec 23, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 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 23, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE DRILL SNAPPED AND BECAME STUCK IN THE DRILL GUIDE. THE CASE WAS COMPLETED WITH A 2 MINUTE DELAY TO SURGERY. THE PATIENT WAS YOUNG WITH HARD BONE AND MAY HAVE PUT THE DRILL UNDER PRESSURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9512733 ↗
• MalfunctionMar 29, 2019Break

  IT WAS REPORTED THAT, ON (B)(6) 2019, DR. WAS FIXING A DISTAL TIBIA FRACTURE. DURING THE IMPLANTING OF TWO DIFFERENT SCREWS, THE SCREWS SNAPPED AND BROKE IN HALF. ADDITIONALLY DURING DRILLING, THE TIP OF THE DRILL BIT BROKE IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8464236 ↗