NA 338640Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327080698), received between Apr 19, 2018 and Jun 25, 2021 — classified as 2 malfunctions.

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

• MalfunctionJun 25, 2021Fracture; Fracture

  AS REPORTED; "WHEN PLACING THE SCREW, IT FRACTURES WHICH MAKES REMOVAL DIFFICULT, A SECOND SCREW MUST BE USED TO REPLACE IT."

  Patient problems: Foreign Body In Patient

  MAUDE report 12071614 ↗
• MalfunctionApr 19, 2018Bent; Material Fragmentation

  DURING MEDICAL INTERVENTION IN TIBIAL SURGERY, AXSOS SCREW WAS DAMAGE (BROKEN) AND PART OF IT REMAIN IN PATIENT, SO SURGEON DECIDED TO REMOVED IT (MORE THAN 40 MINUTES). AFTER THAT THE SURGEON EVIDENCE THAT THE SCREW IN ITS DISTAL PART IS BENT AND SMOOTH. THE SURGEON USE A NEW SCREW (LONGER AXSOS 3.5X50) TO FINALIZE THE MEDICAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7444279 ↗