NA 6901189Recalls & reported problems
Smith & Nephew, Inc. · SOD AIMER ACL FMRL ANTERIOR LTRL ENTRY · Class 1
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 03596010560438), received between Dec 11, 2018 and Dec 11, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (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
- Failure to Align1
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2018Failure to Align; Material Deformation
IT WAS REPORTED THAT DURING ACL PROCEDURE, ALL DEVICES WERE ASSEMBLED. WHEN A GUIDE WIRE PASS THROUGH, USING A BULLET, THE TIPS OF GUIDE WIRE AND AIMER WERE MISALIGNED. IT SEEMS THAT TIP OF AIMER DEFORMED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. 60 MINUTES DELAY WAS REPORTED. THERE WAS NOT PATIENT INJURY, HARM OR COMPLICATIONS DURING OR AFTER THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8151490 ↗
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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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