BIXCUT 0227-6100Recalls & reported problems
Stryker GmbH · IM Reamer, mod. Trinkle Fitting · Class 1
All models of BIXCUT (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540145840), received between Jul 27, 2022 and Jun 23, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- Break1
- Fracture1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
AS REPORTED: "THE REAMER WAS USED TO WIDEN THE FEMORAL MARROW CAVITY. IT WAS DEFEATED BY THE HARD BONE AND THE SHAFT PORTION WAS BENT. THE REAMER WAS NOT BROKEN, SO NO METAL OR OTHER OBJECT WAS IMPLANTED IN THE BODY.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22310689 ↗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." (B)(6) 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 20995779 ↗MalfunctionJul 27, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT IM REAMERS BROKE DURING USE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15113984 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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