Arsenal Foot 307-22-016Recalls & reported problems
Trilliant Surgical, LLC · 2.2mm x 16mm Arsenal Screw · Class 2 · Implant
Data updated Oct 18, 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 00810028390348), received between Aug 26, 2024 and Nov 14, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Deformation Due to Compressive Stress2
- Material Integrity Problem2
Patient problems
- Failure of Implant2
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2024Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem
IT WAS REPORTED THAT THE 2.2X16 NON LOCKING SCREW HEAD BROKE WHILE TIGHTENING INTO A 5 HOLE MINI PLATE, PIECE LEFT IN PATIENT.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 20691777 ↗MalfunctionAug 26, 2024Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem
IT WAS REPORTED THAT THE 2.2X16 NON LOCKING SCREW HEAD BROKE WHILE TIGHTENING INTO A 5 HOLE MINI PLATE, PIECE LEFT IN PATIENT.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 20072567 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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