BIXCUT 0227-6085Recalls & 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 04546540145819), received between Aug 22, 2025 and Feb 13, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Fracture1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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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