RIGIDFIX 213703Recalls & reported problems
Medos International Sàrl · RIGIDFIX Femoral BTB Stepped Trocar · Class 1
All models of RIGIDFIX (19)
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 10886705002979), received between Aug 30, 2018 and Jul 3, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2023Break; Break
IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT THE RIGIDFIX STEPPED TROCAR DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17247314 ↗MalfunctionMar 8, 2023Break; Break
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT THE RIGIDFIX STEPPED TROCAR DEVICE BROKE DUE TO OPERATORS HITTING IT WITH A HAMMER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16504607 ↗MalfunctionAug 30, 2018Break; Break
IT WAS REPORTED PRIOR TO AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE IT WAS NOTICED THAT THE TIP ON HER RIGIDFIX TROCAR WAS BROKEN. THEY SWAPPED THE DEVICE WITH A LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE FACILITY DISCARDED THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7834827 ↗
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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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