ASNIS 325060Recalls & reported problems
Stryker GmbH · Cannulated Screw · Class 2 · Implant
All models of ASNIS (51)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327078138), received between Sep 13, 2021 and Nov 14, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Unraveled Material1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2024Unraveled Material; Unraveled Material
AS REPORTED: "WE WERE USING A 60MM 4.0 STAINLESS SCREW OVER A 1.4 THREADED K WIRE AND THE END OF THE SCREW BECAME UNTHREADED. THE SURGEON HAD TO OPEN ON THE LATERAL SIDE AND THEN HE TOOK WIRE CUTTERS TO CUT OFF THE END THAT BECAME UNTHREADED. AFTER THAT, HE WAS ABLE TO REMOVE THE SCREW AND PUT A DIFFERENT 60MM SCREW IN WHICH DIDN'T HAVE THE SAME ISSUE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20685458 ↗MalfunctionSep 13, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING INSTALLATION OF THE SCREW THE LEADING EDGE THREAD FROM AN ASNIS3 4.0MM PT SCREW SEPARATED FROM THE SCREW AND WAS LEFT IN THE PATIENT. ADVERSE EVENT: LEADING EDGE THREAD FROM AN ASNIS3 4.0MM PT SCREW SEPARATED FROM THE SCREW AND WAS LEFT IN THE PATIENT. MEDICAL INTERVENTION : ATTEMPTS MADE TO REMOVE THE DETACHED THREAD WITH HOOKS, INSTRUMENTS ETC. SURGICAL DELAY: 20 MIN.
Patient problems: Foreign Body In Patient
MAUDE report 12459694 ↗
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- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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