BIXCUT 0226-3140Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540145666), received between Mar 5, 2020 and Mar 5, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PRIMARY PROCEDURE, RIGHT TOTAL HIP ARTHROPLASTY. IT WAS REPORTED THAT THE SURGEON WANTED A FLEXIBLE REAMER. A TRINKLE BIXCUT SHAFT AND BIXCUT IM REAMER HEAD WERE USED. WHEN ASKED, THE SURGEON DECLINED THE USE OF THE GUIDE ROD WITH THE CONSTRUCT. AFTER REAMING, THE REAMER HEAD DISENGAGED FROM THE SHAFT IN THE PATIENT'S FEMUR. AFTER TRYING TO RETRIEVE THE DEVICE, THE SURGEON DECIDED TO LEAVE THE REAMER HEAD IN THE PATIENT. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 15 TO 20 MINUTES. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9795159 ↗