BIXCUT 0225-6090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540145352), received between Nov 15, 2018 and Aug 15, 2025 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (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.

• MalfunctionAug 15, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT "MOST OF THE REAMERS, EVEN AFTER ALL THE MEASURES PUT IN PLACE TO CLEAN THEM, SUCH AS ULTRASONIC CLEANING, SWABBING, AND CONNECTING THEM TO A WASHER-DISINFECTOR TO WASH THE CAVITIES, STILL HAVE TRACES ON THE INSIDE THAT ARE SOMETIMES DIFFICULT TO IDENTIFY, SUCH AS BLOOD OR RED METAL. THESE REAMERS WERE REMOVED AND REPLACED WITH NEW ONES. DESPITE THE VIGILANCE THAT HAS BEEN PUT IN PLACE, IT STILL HAPPENS THAT A DM IS DELIVERED TO THE OR WITH INSUFFICIENT CLEANING, WHICH CAUSES THE DIRT TO BE DILUTED WHEN THE STEAM COMES INTO CONTACT WITH IT, SO THAT THE TRAY CANNOT BE USED - DIRTY REAMERS DETECTED WHEN THE TRAY IS OPENED IN THE OR). AFTER ALL THESE INCIDENTS AND THE NUMBER OF REAMERS REMOVED BECAUSE OF NON-COMPLIANT CLEANING, AND OUR COMMITMENT TO PROVIDING A CLEAN AND FUNCTIONAL DMX, OUR REQUEST IS THAT THE SUPPLIER/MANUFACTURER TAKE THE POSITION OF MAKING THESE DMX SINGLE USE.'' FOR 2024: WE HAD TO ORDER 51 REAMERS, ALL REFERENCES COMBINED, TO REPLACE THE NON-COMPLIANT ONES.''

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821593 ↗
• MalfunctionFeb 11, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT "''MOST OF THE REAMERS, EVEN AFTER ALL THE MEASURES PUT IN PLACE TO CLEAN THEM, SUCH AS ULTRASONIC CLEANING, SWABBING, AND CONNECTING THEM TO A WASHER-DISINFECTOR TO WASH THE CAVITIES, STILL HAVE TRACES ON THE INSIDE THAT ARE SOMETIMES DIFFICULT TO IDENTIFY, SUCH AS BLOOD OR RED METAL. THESE REAMERS WERE REMOVED AND REPLACED WITH NEW ONES. DESPITE THE VIGILANCE THAT HAS BEEN PUT IN PLACE, IT STILL HAPPENS THAT A DM IS DELIVERED TO THE OR WITH INSUFFICIENT CLEANING, WHICH CAUSES THE DIRT TO BE DILUTED WHEN THE STEAM COMES INTO CONTACT WITH IT, SO THAT THE TRAY CANNOT BE USED - DIRTY REAMERS DETECTED WHEN THE TRAY IS OPENED IN THE OR). AFTER ALL THESE INCIDENTS AND THE NUMBER OF REAMERS REMOVED BECAUSE OF NON-COMPLIANT CLEANING, AND OUR COMMITMENT TO PROVIDING A CLEAN AND FUNCTIONAL DMX, OUR REQUEST IS THAT THE SUPPLIER/MANUFACTURER TAKE THE POSITION OF MAKING THESE DMX SINGLE USE.'' FOR 2024: WE HAD TO ORDER 51 REAMERS, ALL REFERENCES COMBINED, TO REPLACE THE NON-COMPLIANT ONES.''.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355478 ↗
• 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 8075092 ↗