BIXCUT 0227-6110Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540145864), received between Jan 22, 2021 and May 27, 2025 — classified as 1 injury, 6 malfunctions.

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

• MalfunctionMay 27, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE FLEXIBLE REAMER IS BROKEN. WE NOTICED AFTER SURGERY. NO DEBRIS WAS NOTICED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087147 ↗
• MalfunctionDec 20, 2024Material Deformation; 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 20995780 ↗
• MalfunctionAug 13, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "I HAVE JUST BEEN CONTACTED BY THE (B)(6) ACCOUNT AND THEY HAVE INFORMED ME THAT 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."

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

  MAUDE report 19972531 ↗
• MalfunctionJun 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING REAMING, THE INSTRUMENT WAS DAMAGED. IT LOOKED LIKE THE INSTRUMENT WAS DAMAGED BY RECOIL WHEN IT HIT A SLIGHTLY HARD BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14826946 ↗
• InjuryJul 2, 2021Break; Break

  IT WAS REPORTED THROUGH MEDWATCH MW5101338 THAT MULTIPLE GRADUATED SIZED REAMERS ARE NEEDED TO PREPARE THE INTRAMEDULLARY CANAL FOR RECEIVING AN ORTHOPEDIC ROD OR NAIL. DURING A PROCEDURE TO REPAIR A LEFT COMMINUTED FEMORAL SHAFT FRACTURE, WHILE REAMING FOR THE INTRAMEDULLARY NAIL, THE FLEXIBLE REAMER BROKE IN THE FEMORAL CANAL. THE REAMER WAS TOO FLEXIBLE AND WOULD NOT ROTATE NOR COULD BE MALLETED OUT. THE SURGEON NEEDED TO TAKE AN ALTERNATE APPROACH FOR RETRIEVAL. THERE WAS AN INCREASED LENGTH OF TIME IN THE OR IN ORDER TO ADDRESS THE ISSUE. THE SURGEON INDICATED A SURGICAL DELAY OF APPROXIMATELY 45 MINUTES. THE PATIENT, DUE TO THIS EVENT, DID RECEIVE MORE ANESTHESIA BUT FROM A CLINICAL STANDPOINT WAS HEMODYNAMICALLY STABLE. THE BROKEN PART OF THE REAMER WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. A NEW SET OF SURGICAL REAMERS WAS OBTAINED AND THE PROCEDURE WAS COMPLETED USING A SECOND ENTRY SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12106492 ↗
• MalfunctionMay 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A GAMMA3 NAIL PROCEDURE, THE BIXCUT REAMER BROKE IN THE PATIENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE CUSTOMER INDICATED THAT THIS DEVICE HAD BEEN REPLACED IN (B)(6) 2020. UPDATE 05/05/2021: PATIENT WAS BEING TREATED FOR PRIMARY, TROCHANTERIC HIP FRACTURE. NORMAL BONE QUALITY. NO IMAGES OR X-RAYS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824310 ↗
• MalfunctionJan 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A RIGHT ANTEGRADE GTN NAIL IMPLANTATION, THE REAMER BROKE OFF INSIDE THE INTRAMEDULLARY CANAL. THE PART WAS RETRIEVED BY REMOVING THE BALL-TIPPED GUIDE WIRE IT WAS ATTACHED TO. NO PIECES REMAINED IN THE PATIENT. REP CAN PROVIDE PICTURES, AND OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11215555 ↗