AXSOS 703539Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540693778), received between Mar 19, 2019 and Jun 26, 2024 — classified as 5 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED: DURING A REMOVAL OF AN AXSOS PLATE AND SCREWS, THE SCREWDRIVER BROKE DURING USE, BASED ON THE AVAILABLE INFORMATION IT IS UNKNOWN IF THE DEVICE BEING BROKEN RESULTED IN DEBRIS WHICH REQUIRED INVASIVE RETRIEVAL. THERE WAS A REPORTED SURGICAL DELAY OF 2-3 HOURS.

  Patient problems: Insufficient Information

  MAUDE report 19613115 ↗
• MalfunctionSep 1, 2022Break; Fracture; Break; Fracture

  A PERIPROSTHETIC SCREW WAS PROPERLY INSERTED. THE SURGEON REALIZED THIS PARTICULAR SCREW WAS TOO LONG AND WANTED TO REMOVE IT. DURING REMOVAL OF THE SCREW, THREE SCREWDRIVERS BROKE AT THE TIP ONE AFTER THE OTHER. THE SURGEON HAD TO BORE OUT THE SCREWHEAD, REMOVE THE PLATE, OVER REAM THE SCREW SHAFT, REMOVE THE REST OF THE SCREW, AND ATTACH A NEW PLATE. THERE WAS A DELAY OF APPROX. 30 MINUTES. NO DEBRIS WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335291 ↗
• MalfunctionFeb 27, 2020Fracture; Fracture

  SCREWDRIVER WAS BEING USED TO BACK OUT A SCREW AND THE TIP BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765363 ↗
• MalfunctionFeb 4, 2020Fracture; Fracture

  IT WAS REPORTED, THAT TWO SCREWDRIVER BITS FOR AXSOS3 5MM WAS BROKEN WHEN ATTEMPTING TO REMOVE A SCREW FROM A PLATE IMPLANTED IN A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9667992 ↗
• MalfunctionMar 19, 2019Break; Component Missing; Material Deformation

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE, THE TIP OF THE SCREWDRIVER WAS OBSERVED TO BE DISFIGURED/ DEFORMED PRIOR TO USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO SURGICAL DELAY. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION WILL NOT BE RELEASED BY THE HOSPITAL OR SURGEON. UPON REVIEW OF RECEIVED DAMAGED DEVICE THE SCREWDRIVER WAS CONFIRMED TO BE BROKEN, THE TIP APPEARS TO BE MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8434673 ↗