BIXCUT 0225-8120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540145420), received between Nov 15, 2018 and Jun 12, 2024 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Failure to Clean Adequately” (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 18, 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.

• MalfunctionJun 12, 2024Failure to Clean Adequately; Failure to Clean Adequately

  AS REPORTED BY THE CUSTOMER: "CLEANING METHODS AVAILABLE TO HSDU ARE INSUFFICIENT TO ENABLE EFFECTIVE AND SAFE DECONTAMINATION OF STRYKER BIXCUT INTRAMEDULLARY FLEXIBLE REAMER. COMPANY GUIDANCE ON DECONTAMINATION IS NOT ALIGNED TO NATIONAL DECONTAMINATION GUIDANCE/BEST PRACTICE. " ON 06/17/2024: ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP INVOLVED INDICATED THAT THE ACCOUNT CONFIRMED THAT FOLLOWING MANUFACTURER IFU THEY ARE UNABLE TO SUCCESSFULLY DECONTAMINATED THE REUSABLE REAMERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522347 ↗
• DeathNov 15, 2018Adverse Event Without Identified Device or Use Problem

  THE SURGEON WAS UNDERTAKING A T2 NAILING PROCEDURE IN A (B)(6) YEAR OLD 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 AN 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 DEVIC

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 8075177 ↗