ASNIS 325032SRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327076042), received between Mar 26, 2024 and May 2, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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 Fragmentation2
- Material Deformation1
- Material Twisted/Bent1
- Unraveled Material1
Patient problems
- Insufficient Information1
- 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.
MalfunctionMay 2, 2024Material Fragmentation; Material Fragmentation
AS REPORTED: "THREAD OF THE ASNIS 4.0X32MM SCREW IS LOOSENING. IN ORDER TO COMPLETE THE SURGERY THE SCREW WAS REMOVED AND NEW SCREW WAS PLACED."
Patient problems: Insufficient Information
MAUDE report 19235316 ↗MalfunctionMar 26, 2024Material Fragmentation; Unraveled Material; Material Deformation; Material Twisted/Bent; Material Fragmentation; Unraveled Material; Material Deformation; Material Twisted/Bent
AS REPORTED: "ON 29.02.2024 AN ASNIS SCREW OF WHICH THE THREAD CAME LOOSE. HE WAS TWISTED INTO A METATARSAL. ANOTHER K-WIRE CROSSED BUT WE DOUBT IF IT WAS IN THE WAY." 26-MAR-2024 - UPDATE. PATIENT INVOLVEMENT?: YES, BUT NO PERMANENT INJURY. PATIENT ADVERSE CONSEQUENCES?: WE WERE ABLE TO REMOVE THE SCREW WAS THE PROCEDURE COMPLETED SUCCESSFULLY?: WE WERE ABLE TO REMOVE THE SCREW IN ITS ENTIRETY AND INSTALL A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18981335 ↗
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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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