ASNIS 325044Recalls & 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 07613327078008), received between Aug 18, 2025 and Aug 18, 2025 — classified as 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2025Material Fragmentation; Material Fragmentation
AS REPORTED: "DURING A SURGERY TO REPAIR A FRACTURED PATELLA THE SURGEON USED ASNIS 4.0 CANNULATED SCREWS. AFTER INSERTING THREE 1.4 THREADED K-WIRES HE DRILLED OVER THEM WITH THE 2.7 CANNULATED DRILL BIT. HE THEN INSERTED THE FIRST TWO SCREWS OVER THE WIRES UNTIL DESIRED COMPRESSION WAS ACHIEVED. DURING INSERTION OF THE THIRD SCREW THE SURGEON FELT UNUSUAL RESISTANCE AND DECIDED TO TAKE AN X-RAY. THE PICTURE REVEALED A METAL FRAGMENT IN THE PATELLA SEPARATE FROM THE SCREWS AND WIRES. AFTER DELIBERATION, THE SURGEON TOOK THE LAST SCREW OUT AND IT APPEARED AS THOUGH THE THREAD ON THE END OF THE SCREW HAD BROKEN OFF IN THE BONE. HE REMOVED AS MUCH OF THE FRAGMENT AS POSSIBLE AND PROCEEDED TO FINISH PLACING ANOTHER SCREW. HE MOVED ON TO CERCLAGE THE PATELLA AND FINISH THE SURGERY".
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 22835236 ↗
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- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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