LEGION 71434341Recalls & reported problems
Smith & Nephew, Inc. · LEGION TIBIAL DRILL GUIDE SIZE 8 · Class 2
All models of LEGION (446)
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 03596010549914), received between Mar 7, 2019 and Apr 22, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2021Crack; Crack
IT WAS REPORTED THAT, DURING A ROUTINE INSPECTION A LEGION TIBIAL DRILL GUIDE SIZE 8 WAS FOUND TO BE CRACKED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11711007 ↗MalfunctionMar 7, 2019Break; Break
IT WAS REPORTED THAT DURING SURGERY THE DEVICE BROKE WHILE USING ON THE PATIENT'S INCISION. ALL BROKEN PIECES WERE RECOVERED, THE PROCEDURE WAS COMPLETED WITH NO DELAYS USING AN S&N BACKUP DEVICE, AND THERE WAS NO INJURY OR AFFECTATION TO THE PATIENT. THE FINAL OUTCOME WAS GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8400387 ↗
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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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