Tiger 210-40-005Recalls & reported problems
Trilliant Surgical, LLC · 0.045in x 6in K-Wire Partially Threaded · Class 1
All models of Tiger (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926021478), received between Dec 9, 2025 and Dec 9, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Mechanical Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
COMPLAINT, THREW 2 BI-CORTICAL THREADED WIRES FOR MALLEOLAR IMPLANTS, WHILE INSERTING ANTERIOR IMPLANT THE SCREW PUSHED WIRE UP AND BENT IT, TRIED TO PULL IT OUT AND BROKE OFF THE TIP AND WAS LEFT IN PATIENT. HAD TO SIZE DOWN TO A UNICORTICAL SCREW TO REPLACE THE BICORTICAL BECAUSE OF BROKEN WIRE STUCK IN TIBIA.
Patient problems: Foreign Body In Patient
MAUDE report 23759411 ↗
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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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