ASNIS 604746SRecalls & reported problems
Stryker GmbH · Cannulated Screw · Class 2 · Implant
All models of ASNIS (51)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540090195), received between Mar 5, 2024 and Mar 5, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (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
- Inaccurate Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Inaccurate Information; Inaccurate Information
AS REPORTED: "THE CUSTOMER PLANNED TO IMPLANT AN ASNIS III 4.0MM SCREW, BUT THE SCREWDRIVER IN THEIR 4.0MM KIT DIDN'T FIT IN THE SCREW HEAD. SO THEY OPENED THE ASNIS 5.0MM INSTRUMENT, TRAY TOOK OUT THE BELONGING SCREWDRIVER FOR ASNIS 5.0MM SCREW AND IMPLANTED THE SCREW WITH THIS SCREWDRIVER. SINCE THEY COULD IMPLANT THE OPENED SCREW WITH THE SCREWDRIVER FROM 5.0MM INSTR. SET, THEY BELIEVE THAT IT WAS A SCREW WITH CORRECT LENGTH BUT THAT IT WAS A 5.0MM SCREW PACKED IN A IMPLANT BOX FOR 4.0MM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18836681 ↗
Other Screw, fixation, bone devices
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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