AXSOS 703540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540693785), received between Feb 4, 2020 and Sep 1, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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.

• MalfunctionSep 1, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A PERIPROSTHETIC SCREW WAS PROPERLY INSERTED. THE SURGEON REALIZED THIS PARTICULAR SCREW WAS TOO LONG AND WANTED TO REMOVE IT. UPON REMOVING IT THREE SCREWDRIVERS BROKE AT THE TIP ONE AFTER THE OTHER. THE SURGEON WOULD ASSUME THE TORXEND TWIST RATHER THAN BREAK. THEREFORE HE HAD TO BORE OUT THE SCREWHEAD, REMOVE THE PLATE, OVERREAM THE SCREWSHAFT, REMOVE THE REST OF THE SCREW AND ATTACH A NEW PLATE. THERE WAS A DELAY OF APPR. 30 MINUTES. THERE WAS NO DEBRIS WAS LEFT IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335286 ↗
• MalfunctionSep 1, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A PERIPROSTHETIC SCREW WAS PROPERLY INSERTED. THE SURGEON REALIZED THIS PARTICULAR SCREW WAS TOO LONG AND WANTED TO REMOVE IT. UPON REMOVING IT THREE SCREWDRIVERS BROKE AT THE TIP ONE AFTER THE OTHER. THE SURGEON WOULD ASSUME THE TORXEND TWIST RATHER THAN BREAK. THEREFORE HE HAD TO BORE OUT THE SCREWHEAD, REMOVE THE PLATE, OVERREAM THE SCREWSHAFT, REMOVE THE REST OF THE SCREW AND ATTACH A NEW PLATE. THERE WAS A DELAY OF APPR. 30 MINUTES. THERE WAS NO DEBRIS WAS LEFT IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335153 ↗
• InjurySep 3, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE LOCKING SCREW WAS PROTRUDING INTO THE ARTICULAR SURFACE, SO SURGERY WAS PERFORMED TO REPLACE IT. DURING THE SURGERY, THE TIP OF THE DRIVER SHAFT WAS BROKEN OFF WHEN THE LOCKING SCREW WAS REMOVED. THE SCREW COULD NOT BE REMOVED USING ANOTHER SCREWDRIVER, WHICH ALSO BROKE, SO A FUTURE REVISION SURGERY WILL BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422265 ↗
• InjurySep 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE LOCKING SCREW WAS PROTRUDING INTO THE ARTICULAR SURFACE, SO SURGERY WAS PERFORMED TO REPLACE IT. DURING THE SURGERY, THE TIP OF THE DRIVER SHAFT WAS BROKEN OFF WHEN THE LOCKING SCREW WAS REMOVED. THE SCREW COULD NOT BE REMOVED USING ANOTHER SCREWDRIVER, SO A FUTURE REVISION SURGERY WILL BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12405685 ↗
• 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 9667911 ↗