BIXCUT 0225-6100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540145376), received between Nov 15, 2018 and Oct 16, 2024 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DURING OSTEOSYNTHESIS SURGERY OF THE FEMUR WITH GAMMA NAIL, THERE OCCURS REAMER BREAKING. THE PROCEDURE WAS COMPLETED WITH THE USE OF OTHER INSTRUMENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462902 ↗
• MalfunctionNov 3, 2020Unraveled Material; Unraveled Material

  THE STRYKER SALES REPRESENTATIVE REPORTED THAT WHILST SUPPORTING A T2 PROXIMAL HUMERAL NAIL CASE AND DURING REAMING THE HUMERUS WITH A FLEXIBLE REAMER, THE REAMER SHAFT UNCOILED WITHIN THE PATIENT. THE SITUATION WAS RECTIFIED. THE HOSPITAL STAFF EXPLAINED THERE WAS A USER ERROR DUE TO THE SURGEON WITHDRAWING THE REAMER ON REVERSE POWER RATHER THAN FORWARD. THE DISTAL PART OF THE REAMER THAT HAD UNCOILED MOST PROMINENTLY CAUGHT ON THE FRACTURE SITE MAKING EXTRACTION VERY DIFFICULT. THIS ADDED AROUND 20-30 MINUTES TO THE SURGICAL TIME. NO RESIDUAL METAL WAS LEFT IN THE PATIENT. THE REAMER SHAFT WAS DETACHED FROM THE POWER TOOL HANDPIECE AND ROTATED GENTLY BY HAND, UNCOILING THE REAMER. THIS ALLOWED THE REAMER TO PASS BY THE FRACTURE SITE WITHOUT CATCHING AND TO BE PULLED BACK OUT THROUGH THE ENTRY SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10781504 ↗
• MalfunctionFeb 7, 2020Fracture; Fracture

  THE SURGEON REPORTED THAT DURING A T2 ANKLE PROCEDURE, THE TIP OF THE FIXED HEAD REAMER BROKE OFF AND THE TIP REMAINS IN THE PATIENT'S TIBIA. THE SURGEON WAS NOT USING A VAULTED GUIDEWIRE WHEN REAMING.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9684863 ↗
• MalfunctionSep 20, 2019Break; Fracture; Material Separation; Fracture

  CUSTOMER REPORTED THE: "INTERVENTION: LEFT TIBIA NAIL. PROBLEM WITH THE REAMING OF THE TIBIAL SHAFT. THE REAMER HAS COMPLETELY DISINTEGRATED AND IS BROKEN AT THE BASE DURING REAMING. VERY HIGH RISK TO THE PATIENT (31 YEARS OLD). THE MATERIAL WAS TRAPPED IN THE TIBIA ON THE REAMING BAR. FORTUNATELY, WE WERE ABLE TO REMOVE THE SET WITHOUT DAMAGING THE PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9099401 ↗
• 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 BEE

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 8075096 ↗