ASNIS 604644SRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540089809), received between Aug 16, 2022 and Mar 24, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Material Fragmentation2
- Break1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2026Fracture
AS REPORTED: "WHEN INSERTING THE SCREW THROUGH THE GUIDE PIN, THE SURGEON FELT A FIRM RESISTANCE. CONTINUING TO INSERT IT, THE SCREWDRIVER BEGAN TO SLIP HALFWAY THROUGH. UPON REMOVING THE GUIDE PIN, THE SCREW ALSO CAME OUT. UPON INSPECTION, IT WAS FOUND THAT THE SCREW WAS BROKEN, AND THE REMAINING BROKEN SCREW FRAGMENT COULD NOT BE REMOVED FROM THE PATIENT'S BODY. THUS, THE SURGERY WAS COMPLETED WHILE THE SCREW FRAGMENT WAS LEFT IN THE PATIENT'S BODY."
Patient problems: Foreign Body In Patient
MAUDE report 24676896 ↗InjuryMar 3, 2023Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation
CUSTOMER REPORTED THAT: "DURING REMOVAL OF OSTEOSYNTHESIS MATERIAL FROM THE PATIENT'S RIGHT ANKLE, ONE OF THE SCREWS BROKE INTO FRAGMENTS. NEED TO OPEN SPECIFIC MATERIAL FOR BROKEN SCREWS. ENLARGEMENT OF THE SCREW HOLE. LENGTHENING OF THE INTERVENTION TIME (20-25 MINUTES). NO CONSEQUENCES FOR THE PATIENT. DM PRESERVED AND CAN BE MADE AVAILABLE FOR EXPERTISE." 22 FEB 2023: CLARIFICATION REGARDING ENLARGEMENT OF SCREW HOLE, THE CUSTOMER REPORTED, "IN ORDER TO REMOVE THE SCREW, WE HAD TO DIG A TUNNEL AROUND IT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16479098 ↗MalfunctionAug 16, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE "SCREW HEAD STRIPPED AND THEY HAD TO LEAVE IT IN THE PATIENT."
Patient problems: Foreign Body In Patient
MAUDE report 15237567 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive 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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