BIXCUT 0227-3000SRecalls & reported problems
Stryker GmbH · Reamer Shaft, Mod.Trinkle · 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 04546540430199), received between Sep 8, 2015 and Mar 18, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Corroded” (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.
Most reported problems
Device problems
- Corroded1
- Device Operates Differently Than Expected1
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2019Corroded; Corroded
STERILE SINGLE USE BIXCUT REAMER SHAFT OPENED IN THEATRE DURING GAMMA NAIL PROCEDURE & SURGEON/SCRUB NURSE HAS IDENTIFIED CORROSION/RUST ON DISTAL END OF INSTRUMENT. REPLACEMENT DEVICE OPENED & USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8428412 ↗MalfunctionJul 9, 2018Fracture; Fracture
FACILITY STATED BIXCUT REAMER TIP BROKE OFF FROM SHAFT. REAMER HEAD WAS LEFT IN PATIENT FEMUR. BALL TIP WIRE WAS NOT USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7671500 ↗MalfunctionSep 8, 2015Device Operates Differently Than Expected
IT WAS REPORTED THAT GUIDE WIRE COULDN'T PASS TO BIXCUT. DR. NOTICED THE BIXCUT HAS SOME PLASTICS LIKE DEBRIS AND DR. USED SPARE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5061960 ↗
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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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