AXSOS 703585Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540694072), received between May 20, 2019 and Apr 4, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "TWO DRILLS BROKE OFF DURING SURGERY AND THE TIP OF THE DRILLS REMAINED TO THE PATIENT BONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 13994869 ↗
• MalfunctionApr 4, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "TWO DRILLS BROKE OFF DURING SURGERY AND THE TIP OF THE DRILLS REMAINED TO THE PATIENT BONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 13994863 ↗
• MalfunctionJun 23, 2021Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING THE PROCEDURE; THE BROKEN-OFF PIECE REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12050055 ↗
• MalfunctionJul 30, 2020Fracture; Fracture

  IT WAS REPORTED, DURING DRILLING THE DRILL BIT RUBBED AGAINST A KIRSCHNER WIRE: DRILL BIT BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10347452 ↗
• MalfunctionOct 11, 2019Break; Detachment of Device or Device Component

  DURING AXSOS PT SURGERY, THE DRILL BIT BROKE WHEN THE SURGEON WAS DRILLING TO THE PATIENT BONE WITH THE DEVISE. THE FRAGMENT WAS REMOVED FROM THE PATIENT. AFTER THAT THE SURGEON DETACHED THE DEVISE AND PERFORMED ORIF PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9179751 ↗
• MalfunctionMay 20, 2019Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING THE DRILLING PROCESS IN SURGERY. THE BROKEN PART IS THE DRILL TIP OF THE DRILL BIT. IT WAS JAMMED IN THE NEAR CORTICAL BONE OF PATIENT. THEY SPENT 2-3 MINUTES TO GET IT OUT EVENTUALLY. NO DISSATISFACTION FROM SURGEON WAS OBSERVED DESPITE THE INCIDENT. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8625519 ↗