NA 121846Recalls & reported problems
Smith & Nephew, Inc. · 4.0MM PARTIALLY THREADED CANNULATED SCREW 46MM · Class 2 · Implant
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 03596010064967), received between Feb 13, 2020 and Jun 10, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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.
Most reported problems
Device problems
- Material Deformation2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING SURGERY, AFTER THE SCREW WAS PLACED AND THE PLANES OF MOTION WERE CHECKED, WHEN TAKING A POST IMAGE, AN IMPLANT DEFORMITY WAS SEEN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW (BACKUP). DELAY UNDER 30 MIN AND NO INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10138197 ↗MalfunctionFeb 13, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING SURGERY, AFTER THE SCREW WAS PLACED AND THE PLANES OF MOTION WERE CHECKED, WHEN TAKING A POST IMAGE, AN IMPLANT DEFORMITY WAS SEEN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW (BACKUP). DELAY UNDER 30 MIN AND NO INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9706308 ↗
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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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