BIXCUT 0225-6110Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540145390), received between Nov 15, 2018 and Feb 13, 2026 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Material Twisted/Bent

  AS REPORTED: "FLEXIBLE PART OF THE REAMER FOUND TO BE DISTENDED DURING INSPECTION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333295 ↗
• MalfunctionAug 19, 2025Break; Fracture; Material Twisted/Bent; Break; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT A REAMER WAS DAMAGED DURING USE. IT OCCURRED DURING A PROCEDURE, BUT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH 30 MINUTES DELAY DUE TO FAILURE TO PREPARE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843527 ↗
• MalfunctionFeb 19, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THERE WAS A RUPTURE OF THE INSTRUMENT DURING SURGERY. 3/1/2024 - UPDATE. NO IMPACT TO THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER REPLACEMENT PRODUCT.

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

  MAUDE report 18729695 ↗
• MalfunctionMay 5, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THE PRODUCT WITH REFERENCE NUMBER (B)(4) WAS BROKEN DURING THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286923 ↗
• MalfunctionJul 7, 2021Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT DURING A REAMING OF A FEMUR, THE STRYKER REAMER MONOBLOC DIAMETER 11 HAS UNWOUND AND REMAINED BLOCKED AT THE LEVEL OF THE FEMUR. THE OPERATOR HAD TO PULL IT OUT BY HAND. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131835 ↗
• MalfunctionDec 8, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT, "DURING THE REAMING OF THE TIBIAL SHAFT WITH THE ENGINE, BY TAKING OUT REAMER NUMBER 11 ,THE DISTAL PART OF IT CAME OFF OF THE STEM AND REMAINED IN THE TIBIAL SHAFT OF THE PATIENT. FORTUNATELY, THE GUIDE ROD THE BUTTONS WE USED ALLOWED US TO EXTRACT IT WITHOUT WORRY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972531 ↗
• MalfunctionJul 15, 2020Fracture; Fracture

  SALES REP REPORTED THAT : "A REAMER BROKE (HEAD) IN THE PATIENT AFTER USE." THE HEAD OF THE REAMER SEEMS TO HAVE STAYED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10279819 ↗
• 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 B

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 8075101 ↗