BIXCUT 0227-8885SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540722324), received between May 28, 2025 and May 28, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "DRILL FRACTURE WHEN DRILLING DISTAL AP LOCKING SCREW OF SUPRAPATELLAR NAIL. THE DRILL CAME OUT SHORT AND IT SHOWS DRILL BIT INTRAOSSEOUS POSTERIOR TO THE NAIL. PROCEDURE COMPLETED SUCCESSFULLY AS THERE WERE 2 ML LOCKING SCREWS USED. NO FURTHER DELAY. NO ADDITIONAL INTERVENTION REQUIRED. THE PLAN WAS TO USE 3 DISTAL LOCKING SCREWS TO OPTIMISE STABILITY IN THE POOR DISTAL TIBIA BONE QUALITY. RIGIDITY OF FIXATION RESULTED TO BE MARGINALLY INFERIOR. THE FRAGMENT IS INTRAOSSEOUS POSTERIOR TO THE NAIL, NOT FEASIBLE TO REMOVE. DISTAL END IS IN THE TIBIA."

  Patient problems: Foreign Body In Patient

  MAUDE report 22100886 ↗