BIXCUT 0227-6075Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540145796), received between Oct 31, 2019 and Oct 23, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Fracture; Fracture

  AS REPORTED: "ORIF FOR DISTAL HUMERUS FRACTURE (T2 HUMERUS NAIL) DURING MEDULLARY CAVITY REAMING WITH A BIG CUT REAMER, THE BASE OF THE 7.5 MM REAMER SHAFT FRACTURED. THE PHYSICIAN THOUGHT THE BREAK OCCURRED DUE TO STRONG RESISTANCE FROM THE NARROW MEDULLARY CAVITY AND HARD BONE IN THIS YOUNG MALE PATIENT, WHICH PLACED STRESS ON THE REAMER'S BASE. NO FRAGMENTS REMAINED INSIDE THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368679 ↗
• MalfunctionOct 6, 2025Fracture; Fracture

  AS REPORTED: "WHEN REAMING THE SPINAL CANAL STARTING AT 7.5MM AS PER THE PROCEDURE, THE TIP OF THE REAMER BROKE OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23223938 ↗
• MalfunctionJul 16, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE SHAFT OF THE FLEXIBLE REAMER BREAKS AT THE BASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518882 ↗
• MalfunctionJun 23, 2025Material Frayed; Material Frayed

  AS REPORTED: "THE EVENT OCCURRED DURING MEDULLARY REAMING IN ORIF FOR THE LEFT TIBIAL SHAFT FRACTURE USING THE FIXED MODIFIED HALL REAMER (0227-6075). THE BONE WAS TOO HARD, CAUSING THE REAMER TO BECOME STUCK MIDWAY, MAKING IT IMPOSSIBLE TO ADVANCE OR REMOVE. IT WAS EVENTUALLY REMOVED MANUALLY BY ROTATING IT. HOWEVER, THE SHAFT OF THE REAMER BECAME FRAYED AND DAMAGED. THERE WAS NO RESIDUAL DEBRIS REMAINING INSIDE THE PATIENT'S BODY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310980 ↗
• MalfunctionAug 13, 2024Break; Fracture; Break; Fracture

  AS REPORTED : ''THE INTRAMEDULLARY NAIL WAS INSERTED MORE THAN 30 YEARS AGO AND THE PATIENT HAD SPENT DECADES SINCE THE NAIL WAS EXTRACTED. THE PATIENT HAD FRACTURED AGAIN AND THE MEDULLARY CAVITY WAS OSTEOSCLEROTIC, SO REAMING WAS STARTED AT 6.0 MM WITH A REAMER ALSO PREPARED FOR THE HUMERUS, ALTHOUGH THE SITE WAS THE FEMUR. AT THE REAMING POINT OF 7.5MM, THE REAMER BECAME VERY HARD AND AFTER REAMING FOR A LONG TIME, THE REAMER BROKE AT ABOUT 10CM IN FRONT OF THE TIP. THE TIP REMAINING IN THE MEDULLARY CAVITY WAS PULLED OUT WITH PLIERS AND REAMED AGAIN WITH A REAMER FOR THE FEMUR.''

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977743 ↗
• MalfunctionJun 7, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DURING PROCEDURE, THE REAMER WAS BROKEN." ADDITIONAL INFORMATION: ALL DEBRIS WERE REMOVED FROM THE PATIENT. THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY.

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

  MAUDE report 19491793 ↗
• MalfunctionOct 31, 2019Break; Dent in Material; Deformation Due to Compressive Stress; Dent in Material; Deformation Due to Compressive Stress

  THE HANDPIECE ROTATION WAS REVERSED DURING DIAPHYSEAL REAMING. BIXCUT WAS DAMAGED BECAUSE THE OPERATION WAS CARRIED OUT WITHOUT REALIZING IT. DEBRIS REMAINED IN THE BODY, BUT WAS REMOVED USING PLIERS AND A HAMMER. AFTER CONFIRMING THAT NO DEBRIS REMAINED IN THE BODY, NAIL FIXATION WAS PERFORMED AND THE OPERATION WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9262918 ↗