BIXCUT 0227-5060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540145765), received between Oct 2, 2023 and Oct 30, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Break; Fracture; Break; Fracture

  FLEXIBLE REAMER BREAKAGE. ROOT OF 6.0 AND 8.0 REAMER BROKEN DURING DISTAL REAMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566205 ↗
• InjuryOct 2, 2023Break; Fracture; Break; Fracture

  THE REAMER WAS BROKEN DURING RE-REVISION OF THA AND TIP PART OF THE REAMER WAS LEFT IN THE PATIENT'S FEMUR ON (B)(6) 2023 (NOTE: THIS RECORD WAS OPENED FOR BROKEN REAMER AND ANOTHER PI WAS OPENED FOR RE-REVISION). AFTER REMOVING CEMENT TO SOME EXTENT, REAMING WAS PERFORMED USING 6MM FLEXIBLE REAMER. HOWEVER, TIP OF THE REAMER GOT STUCK WITH CEMENT IN THE MEDULLARY CAVITY OF A BONE. THE SURGEON TRIED TO REMOVE THE REAMER BY REAMING AGAIN AND AGAIN, BUT THE SHAFT OF THE REAMER WAS BROKEN AND TIP PART OF THE REAMER WAS LEFT IN THE CEMENT. BECAUSE THE SURGERY TOOK A VERY LONG TIME, THE SURGEON DECIDED THAT THE FEMORAL IMPLANT WOULD BE REMOVED AT A LATER DATE, AND THE SURGERY WAS FINISHED WHILE THE TIP PART OF THE BROKEN REAMER STILL IN THE PATIENT'S BODY. THE SURGEON TOLD THAT ABOUT A MONTH LATER, WHEN THE PATIENT IS READY FOR SURGERY, HE WILL PERFORM THE SURGERY AGAIN AND TREAT THE FEMORAL SIDE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17850594 ↗