RIGIDFIX 213705Recalls & reported problems
Medos International Sàrl · RIGIDFIX Mallet · 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 10886705002993), received between Mar 15, 2021 and Oct 21, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2022Break; Break
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CANADA THAT THE RIGIDFIX MALLET NON-STERILE BROKE IN TWO. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15653788 ↗MalfunctionMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDLE ON THE RIGIDFIX MALLET DEVICE CAME OFF THE SURGEON'S HAND. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11784995 ↗MalfunctionMar 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HANDLE ON THE RIGIDFIX MALLET DEVICE CAME OFF THE SURGEON'S HAND. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11486035 ↗
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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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