NA 234-020-044Recalls & reported problems
Stryker Corporation · 4MM FEMORAL AIMER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154174812), received between Dec 12, 2019 and Mar 16, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (3 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 16, 2026.
Most reported problems
Device problems
- Mechanical Jam3
- Overheating of Device1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2020Mechanical Jam; Mechanical Jam
PER INVESTIGATION RESULTS, THE TIP OF THE DEVICE WAS BROKEN OFF. PER THE EVENT DESCRIPTION, THERE IS NO ALLEGED PATIENT INVOLVEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9835924 ↗MalfunctionMar 16, 2020Mechanical Jam; Mechanical Jam
PER INVESTIGATION RESULTS, IT WAS REPORTED THAT THE GUIDE WAS BLOCKED, WHICH COULD POTENTIALLY LEAD TO OVERHEATING. THERE IS NO ALLEGED PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9835908 ↗MalfunctionDec 12, 2019Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam
IT WAS REPORTED THAT THERE WAS A POTENTIAL OF THE DEVICE OVERHEATING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9461178 ↗
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- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 reports
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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