BIXCUT 0225-6095Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540145369), received between Nov 15, 2018 and Jan 6, 2025 — classified as 1 death, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025Break; Fracture; Break; Fracture

  A BROKEN REAMER WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21088114 ↗
• MalfunctionNov 29, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE HEAD OF A REAMER BROKE OFF FROM THE SHAFT DURING THE REAMING, HOWEVER THERE WAS NO REPORTED DEBRIS. THE PROCEDURE WAS COMPLETED WITH A LARGER BORING SHAFT, BUT THIS RESULTED IN A 10 MINUTE DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883251 ↗
• DeathNov 15, 2018Adverse Event Without Identified Device or Use Problem

  THE SURGEON WAS UNDERTAKING A T2 NAILING PROCEDURE IN A (B)(6) FEMALE PATIENT . AT THE START OF THE CASE DURING REAMING WITH BIXCUT REAMERS, THE PATIENT HAD A PULMONARY EMBOLISM. THE SURGEONS ATTEMPTED RESUSCITATION AND TRANSFERRED THE PATIENT TO ITU BUT THE PATIENT PASSED AWAY SOME TIME LATER. THERE WERE NO REPORTS OF ANY ISSUES WITH THE BIXCUT REAMER DURING USE AND THE T2 NAIL HAD NOT BEEN IMPLANTED. UPDATE: THE PATIENT WAS A (B)(6) FEMALE, OVERWEIGHT (HIGH BMI). SHE ATTEMPTED A HALF MARATHON ON (B)(6) 2018 BUT DROPPED OUT. SHE COMPLAINED TO A&E OF THIGH PAIN, A STRESS FRACTURE WAS LATER NOTED AFTER 3 VISITS TO HOSPITAL AND WAS ADMITTED FOR A IM NAIL PROCEDURE. THE CASE WAS PROGRESSING AS PLANNED WITHOUT INCIDENT; HOWEVER, THERE WAS A SPIRAL FRACTURE WHICH THE SURGEONS FACE DIFFICULTY IN REDUCING. FOLLOWING REDUCTION THE SURGEON STARTED REAMING USING THE BIXCUT REAMERS THE ANAESTHETIST REPORTED A PE AND THE NEED TO INTUBATE AND THE SURGEON STOPPED THE PROCEDURE. FOLLOWING THIS THEY STARTED TO STABILISE THE PATIENT AND PERFORM CPR. AFTER 15 MINS THE ANAESTHETIST CONFIRMED THAT SHE WOULD NOT BE FIT FOR CONTINUATION WITH THE NAIL EVEN IF SHE WAS STABILIZED. ALL OF THESE DEVICES "HAS

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 8075093 ↗