BIXCUT 0225-6080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540145338), received between May 2, 2018 and Aug 15, 2025 — classified as 10 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT "MOST OF THE REAMERS, EVEN AFTER ALL THE MEASURES PUT IN PLACE TO CLEAN THEM, SUCH AS ULTRASONIC CLEANING, SWABBING, AND CONNECTING THEM TO A WASHER-DISINFECTOR TO WASH THE CAVITIES, STILL HAVE TRACES ON THE INSIDE THAT ARE SOMETIMES DIFFICULT TO IDENTIFY, SUCH AS BLOOD OR RED METAL. THESE REAMERS WERE REMOVED AND REPLACED WITH NEW ONES. DESPITE THE VIGILANCE THAT HAS BEEN PUT IN PLACE, IT STILL HAPPENS THAT A DM IS DELIVERED TO THE OR WITH INSUFFICIENT CLEANING, WHICH CAUSES THE DIRT TO BE DILUTED WHEN THE STEAM COMES INTO CONTACT WITH IT, SO THAT THE TRAY CANNOT BE USED - DIRTY REAMERS DETECTED WHEN THE TRAY IS OPENED IN THE OR). AFTER ALL THESE INCIDENTS AND THE NUMBER OF REAMERS REMOVED BECAUSE OF NON-COMPLIANT CLEANING, AND OUR COMMITMENT TO PROVIDING A CLEAN AND FUNCTIONAL DMX, OUR REQUEST IS THAT THE SUPPLIER/MANUFACTURER TAKE THE POSITION OF MAKING THESE DMX SINGLE USE.'' FOR 2024: WE HAD TO ORDER 51 REAMERS, ALL REFERENCES COMBINED, TO REPLACE THE NON-COMPLIANT ONES.''

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821409 ↗
• MalfunctionFeb 11, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT "''MOST OF THE REAMERS, EVEN AFTER ALL THE MEASURES PUT IN PLACE TO CLEAN THEM, SUCH AS ULTRASONIC CLEANING, SWABBING, AND CONNECTING THEM TO A WASHER-DISINFECTOR TO WASH THE CAVITIES, STILL HAVE TRACES ON THE INSIDE THAT ARE SOMETIMES DIFFICULT TO IDENTIFY, SUCH AS BLOOD OR RED METAL. THESE REAMERS WERE REMOVED AND REPLACED WITH NEW ONES. DESPITE THE VIGILANCE THAT HAS BEEN PUT IN PLACE, IT STILL HAPPENS THAT A DM IS DELIVERED TO THE OR WITH INSUFFICIENT CLEANING, WHICH CAUSES THE DIRT TO BE DILUTED WHEN THE STEAM COMES INTO CONTACT WITH IT, SO THAT THE TRAY CANNOT BE USED - DIRTY REAMERS DETECTED WHEN THE TRAY IS OPENED IN THE OR). AFTER ALL THESE INCIDENTS AND THE NUMBER OF REAMERS REMOVED BECAUSE OF NON-COMPLIANT CLEANING, AND OUR COMMITMENT TO PROVIDING A CLEAN AND FUNCTIONAL DMX, OUR REQUEST IS THAT THE SUPPLIER/MANUFACTURER TAKE THE POSITION OF MAKING THESE DMX SINGLE USE.'' FOR 2024: WE HAD TO ORDER 51 REAMERS, ALL REFERENCES COMBINED, TO REPLACE THE NON-COMPLIANT ONES.''

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

  MAUDE report 21355475 ↗
• MalfunctionSep 29, 2023Break; Fracture; Difficult to Remove; Material Deformation; Break; Fracture; Difficult to Remove; Material Deformation

  THE CUSTOMER REPORTED: "REAMER PERFORMANCE/QUALITY FAULT (STRYKER) DURING BONE DRILLING, THE REAMER SHAFT BROKE WHILE THE MOTOR WAS APPLYING ROTATION FOR REAMING. WHEN THE REAMER WAS REMOVED, THE 1ST STEEL TWIST DEFORMED, MAKING IT VERY DIFFICULT TO REMOVE THE DEVICE. THIS HAD AN IMPACT ON THE OPERATING TIME, WHICH WAS LENGTHENED BY THE LABORIOUS REMOVAL OF THE DEVICE. IMMEDIATELY AFTER REMOVAL OF THE REAMER, THE OPERATING TEAM TOOK AN X-RAY TO CHECK THAT THERE WAS NO DEBRIS/FOREIGN BODIES IN THE PATIENT'S BONE TISSUE. THE X-RAY CONFIRMED THAT THERE WAS NO DEBRIS AND THAT THE OPERATION COULD CONTINUE. CURRENT STATE OF THE PATIENT: CONSEQUENCES: SIGNIFICANT LOSS OF OPERATING TIME, ESTIMATED AT 20 MINUTES. CRITICAL INCIDENT FOR THE PATIENT, WHO FORTUNATELY SUFFERED NO IMPACT. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: PAINSTAKING REMOVAL OF DEVICE OF THE DEVICE. X-RAY CONFIRMED ABSENCE OF DEBRIS AND POSSIBILITY OF CONTINUING THE OPERATION. CHANGE OF THE MEDICAL DEVICE WITH LARGER REAMER TO CONTINUE THE OPERATION. THERE WAS ALSO A SIGNIFICANT ECONOMIC LOSS DUE TO THE LOSS OF THE RE-STERILISABLE DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17847995 ↗
• MalfunctionMar 4, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THAT: "19-YEAR-OLD PATIENT, UNDERGOING OSTEOSYNTHESIS SURGERY BY A SHIN NAIL ON THE LEFT FOLLOWING A FRACTURE OF THE LEFT LEG. THE REAMER HAS BROKEN DURING THE REAMING OF THE LEFT TIBIAL SHAFT OF THE PATIENT. THE BROKEN PIECE WAS RECOVERED. THE REAMER WAS PUT INTO OPERATION ON (B)(6) 2016 AND STERILIZED 358 TIMES. CLINICAL CONSEQUENCES AND CURRENT STATUS OF THE PATIENT OR PERSON INVOLVED: LENGTHENING OF THE OPERATING TIME. RISK OF LOSS OF AN ELEMENT IN THE TIBIAL SHAFT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11413218 ↗
• MalfunctionJul 15, 2020Fracture; Fracture

  CUSTOMER REPORTED TO SALES REP THAT: "BREAKAGE OF A REAMER DURING PROCEDURE" PROCEDURE ENDED BY CHANGING REAMER." EMAIL FROM CUSTOMER FROM 26-06-2020 : UPDATE ¿INDEED I CAN CONFIRM WE HAVE A REAMER BIXCUT STRYKER DIAM 8 REF K0008F1 THAT BROKE DURING THE SURGERY ON (B)(6) 2020."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10278884 ↗
• MalfunctionFeb 3, 2020Break; Break

  SALES REP REPORTED THAT : "FOLLOWING AN OPERATION ON A YOUNG PATIENT WITH A THICK CORTEX, THE REAMERS BROKE." THE DEVICE WAS CHANGED TO PROCEED WITH THE PROCEDURE WITH A DELAY OF 5MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9661584 ↗
• MalfunctionFeb 3, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  SALES REP REPORTED THAT : "FOLLOWING AN OPERATION ON A YOUNG PATIENT WITH A THICK CORTEX, THE REAMERS BROKE." THE DEVICE WAS CHANGED TO PROCEED WITH THE PROCEDURE WITH A DELAY OF 5MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9661571 ↗
• MalfunctionFeb 3, 2020Break; Unraveled Material; Naturally Worn; Break; Unraveled Material; Naturally Worn

  SALES REP REPORTED THAT : "FOLLOWING AN OPERATION ON A YOUNG PATIENT WITH A THICK CORTEX, THE REAMERS BROKE." THE DEVICE WAS CHANGED TO PROCEED WITH THE PROCEDURE WITH A DELAY OF 5MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9661542 ↗
• MalfunctionSep 18, 2019Difficult to Remove; Mechanical Jam; Mechanical Jam

  RISK MANAGER REPORTED: "FAILURE WHEN ATTEMPTING TO REMOVE THE REAMER, IT WAS NECESSARY TO INSTALL THE MOTOR ON THE REAMER GUIDE AND REMOVE THE GUIDE + REAMER ASSEMBLY. CONSEQUENCES : DELAY AND INCREASED RISK OF INFECTION. RISK OF AGGRAVATION OF THE FRACTURE AND DELAY IN CONSOLIDATION." PROCEDURE WAS OTHERWISE COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9085095 ↗
• MalfunctionMay 2, 2018Fracture

  THE PHARMACIST AT THE CLINIC, REPORTED THE FOLLOWING EVENT TO THE SALES REP : "RUPTURE OF THE GUIDE WIRE REF (B)(4) INTO THE REAMER SHAFT DIAM 8. THE GUIDE COULD NOT SLIDE AND FINALLY FRACTURED INTO THE SHAFT. IS IT A WEAR FAIL DOCTOR INDICATED THAT THE EVENT OCCURED DURING A TIBIAL NAILING. THERE WAS A DELAY IN THE PROCEDURE, INCREASE OF THE INFECTION RISK AND PEROPERATIVE FRACTURE. IT WAS NECESSARY TO CHANGE THE GUIDE AND TO REDUCE THE FRACTURE AGAIN.

  Patient problems: No Information

  MAUDE report 7481263 ↗