BIXCUT 0227-6080Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540145802), received between Jul 18, 2019 and Nov 13, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Fracture; Fracture

  AS REPORTED: "THE SHAFT BROKE DURING MEDULLARY CANAL REAMING. IT WAS USED CORRECTLY AND THERE WAS NO REVERSE ROTATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550490 ↗
• MalfunctionOct 16, 2025Fracture; Material Deformation; Device Handling Problem; Fracture; Material Deformation; Device Handling Problem

  BROKEN DURING DIAPHYSEAL REAMING. USED IN REVERSE ROTATION. UPDATE SEPTEMBER 18, 2025. HOW WAS THE EVENT RESOLVED? THE 8.0MM REAMER BROKE, SO AN 8.5MM REAMER WAS USED INSTEAD. THE REAMER WAS REMOVED BY BACKSTROKING IT WITH PLIERS AND A HAMMER. IF THE DEVICE WAS BROKEN OR DAMAGED: WAS THERE HARD/DENSE BONE? UNKNOWN BUT PATIENT WAS IN THEIR 40'S SO, IT WAS NOT SOFT. WAS THERE ANY DEBRIS REPORTED? WERE THEY ALL REMOVED FROM THE SURGICAL FIELD/PATIENT? NO FRAGMENTS WERE VISIBLE TO THE NAKED EYE. X-RAYS WERE TAKEN DURING AND POST-SURGERY, BUT NO FRAGMENTS WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316688 ↗
• MalfunctionOct 10, 2025Material Deformation; Material Deformation

  AS REPORTED: "AFTER REMOVAL OF THE MRS STEM, A REAMER WAS USED TO REMOVE CEMENT, THE REAMERS BROKE. NO BROKEN PIECES WERE GENERATED, AND THE SHAFT OF THE REAMER WAS STRETCHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263715 ↗
• MalfunctionDec 20, 2024Crack; Material Deformation; Crack; Material Deformation

  AS REPORTED: "MECHANICAL DAMAGE OF REAMERS DURING REAMING OF TIBIAL BONE. EVERY NEXT REAMER WERE BLOCKING IN MARROW CAVITY. THEY WERE USED ACCORDING TO INSTRUCTION FOR USE, STARTING FROM THE SMALLEST. IN THE END REPLACEMENT DEVICE FROM DIFFERENT COMPANY HAS BEEN USED. NOTHING LEFT IN PATIENT BODY." 12/19/2024 - ADDITIONAL INFORMATION RECEIVED: DEFORMATION OF THE DEVICE, DEVICE WAS CHANGED DUE TO POSSIBILITY OF BREAKING. ALL INSTRUMENTS USED TO DRILL WERE COMPATIBLE WITH BIXCUT REAMERS. THERE WERE USED STRYKER¿S POWER TOOLS WITH ALL APPROPRIATE ATTACHMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20995781 ↗
• MalfunctionNov 23, 2024Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  AS REPORTED: "THE TIP OF THE 8 MM REAMER SHAFT WAS DAMAGED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766527 ↗
• MalfunctionOct 30, 2024Break; Fracture; Break; Fracture

  FLEXIBLE REAMER BREAKAGE. ROOT OF 6.0 AND 8.0 REAMER BROKEN DURING DISTAL REAMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566210 ↗
• MalfunctionOct 9, 2024Break; Fracture; Material Deformation; Mechanical Jam; Device Handling Problem; Break; Fracture; Material Deformation; Mechanical Jam; Device Handling Problem

  AS REPORTED: "TIP STUCK IN MEDULLARY CAVITY DURING REAMING AND DAMAGED WHEN TRYING TO TURN WITH HANDPIECE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412353 ↗
• InjurySep 16, 2024Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  AS REPORTED: "A BIXCUT REAMER HAS SNAPPED INSIDE THE PATIENT. THE COIL PART OF THE REAMER UNCOILED DURING USE WHILST USING A GUIDEWIRE, REMOVED AND X-RAYED PATIENT NOTHING REMAINED IN PATIENT." CASE TYPE: IM FIXATION OF THE TIBIA THE PROCEDURE WAS COMPLETED WITH 30 MIN OF DELAY BY USING ANOTHER SET OF INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226409 ↗
• MalfunctionJun 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT: "WHEN DOING A TIBIAL NAIL THE REAMER METAL STARTED TO UNRAVEL WHILE IT WAS IN THE PATIENTS TIBIA. SURGEON ABLE TO SLAP IT OUT WITH NO APPARENT HARM TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17241441 ↗
• MalfunctionOct 14, 2020Fracture; Fracture

  THE INCIDENT OCCURRED DURING INSERTION OF THE INTRAMEDULLARY NAIL INTO THE FEMUR. THE MEDULLARY CANAL OF THE FEMUR WAS DRILLED WITH A UNIFORM REAMER WITH A DIAMETER OF 8.0 MM ALONG THE GUIDE. AFTER REACHING THE OPTIMAL DRILLING LENGTH, THE REAMER WAS WITHDRAWN. THE REAMER CAME OUT, HOWEVER, ITS DISTAL FRAGMENT, APPROX. 3-4 CM LONG, REMAINED AT THE END OF THE GUIDE IN THE MEDULLARY CANAL. THE GUIDE WAS REMOVED ALONG WITH THE DAMAGED PART OF THE REAMER. SUBSEQUENTLY, FURTHER WIDENING OF THE MEDULLARY CANAL WAS STARTED USING LARGER SIZE REAMERS. THERE WAS NO PART OF THE REAMER LEFT IN THE PATIENT'S BODY - IT WAS REMOVED ALONG WITH THE GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10681046 ↗
• MalfunctionJul 18, 2019Unraveled Material

  DURING INTRAMEDULLARY NAIL SURGERY, THE REAMER SHAFT UNRAVELED IN THE PATIENT BONE BECAUSE THE SURGEON TURNED THE POWER TOOL BACKWARDS. THE REAMER SHAFT WAS REMOVED FROM THE PATIENT WITHOUT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804880 ↗