BIXCUTRecalls & reported problems across all models
Stryker GmbH · 34 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 104
- Deaths reported
- 12
- Injuries reported
- 6
- Recalls
- 0
We found 34 models of BIXCUT by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 104 adverse event reports in the FDA's MAUDE database, received between Sep 8, 2015 and Feb 16, 2026 — classified as 12 deaths, 6 injuries, 86 malfunctions.
The most frequently reported specific device problem is “Fracture” (42 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BIXCUT problems
Device problems
- Fracture42
- Break37
- Failure to Clean Adequately15
- Material Deformation14
- Adverse Event Without Identified Device or Use Problem12
- Material Twisted/Bent8
- Unraveled Material4
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- Insufficient Information15
- Death12
- No Known Impact Or Consequence To Patient12
- Pulmonary Embolism12
- Device Embedded In Tissue or Plaque4
- No Consequences Or Impact To Patient4
- Foreign Body In Patient3
BIXCUT models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIXCUT 0227-6080Orthopedic Manual Surgical Instrument11 reports
- BIXCUT 0225-6080ORTHOPEDIC MANUAL SURGICAL INSTRUMENT10 reports
- BIXCUT 0225-6110ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death8 reports
- BIXCUT 0227-6075Orthopedic Manual Surgical Instrument7 reports
- BIXCUT 0227-6110Orthopedic Manual Surgical Instrument7 reports
- BIXCUT 0225-6085ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- BIXCUT 0225-6100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death5 reports
- BIXCUT 0227-6105Orthopedic Manual Surgical Instrument5 reports
- BIXCUT 0225-6075ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- BIXCUT 0225-6090ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death3 reports
- BIXCUT 0225-6095ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death3 reports
- BIXCUT 0225-6105ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death3 reports
- BIXCUT 0227-6085Orthopedic Manual Surgical Instrument3 reports
- BIXCUT 0227-6100Orthopedic Manual Surgical Instrument3 reports
- BIXCUT 0227-3000SORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- BIXCUT 0227-8510SORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- BIXCUT 0225-8120ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death2 reports
- BIXCUT 0227-5060Orthopedic Manual Surgical Instrument2 reports
- BIXCUT 0226-3000SORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- BIXCUT 0225-8115ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death1 report
- BIXCUT 0225-8125ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death1 report
- BIXCUT 0225-8130ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death1 report
- BIXCUT 0225-8135ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death1 report
- BIXCUT 0225-8140ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death1 report
- BIXCUT 0225-8145ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 death1 report
- BIXCUT 0226-3140ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- BIXCUT 0227-5065Orthopedic Manual Surgical Instrument1 report
- BIXCUT 0227-6090Orthopedic Manual Surgical Instrument1 report
- BIXCUT 0227-6095Orthopedic Manual Surgical Instrument1 report
- BIXCUT 0227-8115Orthopedic Manual Surgical Instrument1 report
- BIXCUT 0227-8885SORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- BIXCUT 0225-5060ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- BIXCUT 0225-5065ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- BIXCUT 0225-5070ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent BIXCUT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Fracture
AS REPORTED: "WHEN USING THE 10.5 MM DRILL BIT IN THE TIBIAL CANAL TO ENLARGE THE CANAL BEFORE INSERTING THE ROD, THE DRILL BIT BROKE, LEAVING A PART OF THE TREPHINE AND ANOTHER PART IN THE PATIENT'S TIBIA, WHICH WERE SUBSEQUENTLY REMOVED DURING THE CONTINUATION OF THE PROCEDURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345798 ↗MalfunctionFeb 13, 2026Material Twisted/Bent
AS REPORTED: "FLEXIBLE PART OF THE REAMER FOUND TO BE DISTENDED DURING INSPECTION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333295 ↗MalfunctionFeb 13, 2026Fracture
IT WAS REPORTED THAT, REAMER SHAFT BROKE DURING REAMING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333111 ↗MalfunctionDec 21, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE REAMER WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861060 ↗MalfunctionDec 3, 2025Material Twisted/Bent; Material Twisted/Bent
AS REPORTED: "DURING THE THA SURGERY ON (B)(6) 2025, A 9MM FLEXIBLE REAMER WAS USED TO REAM THE FEMORAL MEDULLARY CAVITY. DUE TO THE NARROW MEDULLARY CAVITY, THE REAMER WAS USED WITHOUT A GUIDE WIRE. BECAUSE OF THE NARROW MEDULLARY CAVITY, STRESS WAS PLACED ON THE INSTRUMENT DURING REAMING, CAUSING IT TO BREAK (BEND). NO INSTRUMENT PARTS REMAINED INSIDE THE PATIENT DUE TO THE BREAKAGE. THE SURGERY CONCLUDED WITHOUT ISSUES, AND WE HAVE BEEN INFORMED THAT NO HEALTH COMPLICATIONS HAVE BEEN REPORTED TO DATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23706963 ↗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 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 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 23265545 ↗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 ↗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 ↗MalfunctionAug 22, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
AS REPORTED: "SHAFT DAMAGE OF THE REAMER SHAFT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22877655 ↗MalfunctionAug 19, 2025Break; Fracture; Material Twisted/Bent; Break; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT A REAMER WAS DAMAGED DURING USE. IT OCCURRED DURING A PROCEDURE, BUT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH 30 MINUTES DELAY DUE TO FAILURE TO PREPARE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22843527 ↗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 22821593 ↗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 OPERATING ROOM). 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 22821584 ↗
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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