EVOS 72465107Recalls & reported problems
Smith & Nephew, Inc. · EVOS 2.7MM/3.5MM LATERAL DISTAL FIBULA PLATE 7 HOLE LEFT 103MM · Class 2 · Implant
All models of EVOS (190)
Data updated Oct 16, 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 00885556641231), received between Jan 26, 2026 and Jan 26, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Positioning1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Difficult or Delayed Positioning
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION ANKLE SURGERY, THE 3 MORE DISTAL HOLES OF ONE (1) EVOS 2.7/3.5 L-D FIBULA PL 7H L 103MM WOULD NOT ALLOW A 2.7MM LOCKING SCREW TO LOCK INTO THE PLATE. A NEW HOLE WAS DRILLED AND A NEW SCREW WAS USED AND FOUND THE SAME RESULT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE BUT WITH 4.0MM CANCELLOUS SCREWS. THE SURGEON WAS HAPPY WITH THE OUTCOME USING THE 4.0 CANCELLOUS SCREW. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 24177245 ↗
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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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