ASNIS 604646Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540089816), received between May 13, 2019 and Sep 10, 2021 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Adverse Event Without Identified Device or Use Problem2
- Fracture1
Patient problems
- Reaction2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A LEFT ELBOW DISLOCATION FRACTURE SURGERY THE CANNULATED SCREW ASNIS 3, 4,0X46MM BROKE IN 2 PARTS DURING INSERTION; THE DISTAL PART REMAINED FIXED WITHIN THE SKELETAL SEGMENT, ITS REMOVAL COULD HAVE JEOPARDIZED THE OUTCOME OF THE SURGERY. CONSEQUENTLY, THE SCREW HAD TO BE REPLACED, DELAYING THE EXECUTION OF THE SURGICAL PROCEDURE. THE LENGTH OF THE DELAY HAS NOT BEEN REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 12452597 ↗InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem
COMPLAINANT CALLED ON BEHALF OF PATIENT, STATING PATIENT HAD STRYKER SCREWS AND NAILS USED IN THEIR BROKEN ANKLE IN (B)(6) 2018. SINCE THIS DATE, PATIENT HAS BEEN HAVING ALLERGIC REACTIONS AND IT HAS NOT YET BEEN CONFIRMED WHAT IS THE CAUSE.
Patient problems: Reaction
MAUDE report 8605979 ↗InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem
COMPLAINANT CALLED ON BEHALF OF PATIENT, STATING PATIENT HAD STRYKER SCREWS AND NAILS USED IN THEIR BROKEN ANKLE IN (B)(6) 2018. SINCE THIS DATE, PATIENT HAS BEEN HAVING ALLERGIC REACTIONS AND IT HAS NOT YET BEEN CONFIRMED WHAT IS THE CAUSE.
Patient problems: Reaction
MAUDE report 8605928 ↗
Other Screw, fixation, bone devices
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- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- 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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