RIGIDFIX 213718Recalls & reported problems
Medos International Sàrl · RIGIDFIX Femoral Rod Soft Tissue Only 8.5mm, 30-120mm (Plus or Minus 6 Percent) · Class 1
Data updated Oct 13, 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 10886705003099), received between Sep 29, 2018 and Feb 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam2
- Device-Device Incompatibility1
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.
MalfunctionFeb 10, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED BY THAT DURING ANTERIOR CRUCIATE LIGAMENT PROCEDURE, IT WAS OBSERVED THAT THE RIGIDFIX FEM ROD, 8.5MM DEVICE WAS STUCK IN THE GUIDE AND COULD NOT BE REMOVED. THE DEVICE WAS DISPOSED OF. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342616 ↗MalfunctionSep 29, 2018Mechanical Jam; Mechanical Jam
IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL REPAIR PROCEDURE THE SALES REP'S RIGIDFIX FEMORAL GUIDE HAD THE THUMB SCREW BREAK INSIDE THE GUIDE. THE BREAK IN THE SCREW HAPPENED OUTSIDE OF THE PATIENT WITH NO FRAGMENTS CREATED. THE SALES REP'S 8.5 RIGIDFIX FEMORAL ROD IS JAMMED IN THE GUIDE BECAUSE THE SCREW CANNOT BE REMOVED FROM THE GUIDE. THE CASE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT HARM OR DELAYS. THE DEVICES ARE BEING RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7921257 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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