ASNIS 325050SRecalls & 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
- 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 07613327076226), received between Aug 17, 2021 and Apr 3, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (3 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 18, 2026.
Most reported problems
Device problems
- Material Deformation3
- Material Twisted/Bent1
- Migration1
Patient problems
- Failure of Implant1
- Insufficient Information1
- 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.
MalfunctionApr 3, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
THE CUSTOMER REPORTED 'WHEN THE SCREW WAS INSERTED IN THE PATIENT AT THE TIME OF THE INTRAOPERATIVE X-RAY CHECK, THE SURGEON REALIZED THAT THE SCREW WAS LOOSENING AND WOULD LEAVE A FOREIGN BODY IN THE PATIENT'S ELBOW. THE SURGEON REMOVED THE SCREW WITH DIFFICULTY AND WE FOUND THAT THE SCREW WAS COMPLETELY TWISTED AT THE END AND DEFORMED.'.
Patient problems: Insufficient Information
MAUDE report 16667397 ↗MalfunctionMar 12, 2022Material Deformation; Material Deformation
AS REPORTED: "OSTEOSYNTHESIS OF THE TIBIA AND FIBULA, THE 4.0 CANNULATED SCREWS WERE PLACED, AND ONE OF THEM WAS DEFORMED, THE SCREWS WERE PLACED BY HAND, NO MOTOR WAS USED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13744288 ↗InjuryAug 17, 2021Material Deformation; Migration; Material Deformation; Migration
THE CUSTOMER REPORTED THAT: "THE SCREW WAS DEFORMED IN THE PATIENT'S ELBOW AFTER THE OSTEOSYNTHESIS. THIS WAS DETECTED DURING THE CONTROL SCAN, I.E. DURING THE OPERATION. VISUALIZATION OF A PART OF THE SCREW DISMANTLED AND PITTED NEAR THE PATIENT'S ULNAR NERVE. THE SCREW HAD TO BE REMOVED BY ANOTHER APPROACH. SURGICAL DELAY OF 30 MINUTES."
Patient problems: Failure of Implant
MAUDE report 12332891 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- 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 STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page