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Mimix, CUDA LE-35CUPRecalls & reported problems

Conmed Corporation · Mimix 35 Degree Cuda Stealth, 3.5 mm · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854901707), received between Oct 18, 2019 and Oct 18, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Disintegration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Disintegration1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 18, 2019Material Disintegration; Material Disintegration

    ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED ISSUES WITH THE LE-35CUP, MIMIX 3.5MM X 8CM, CUDA, 35 DEGREE, STEALTH, LOT 1024527, EXPERIENCED ON (B)(6) 2019 IN (B)(6). IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY PROCEDURE ON (B)(6) 2019, A LE-35CUP WAS USED. IT DETACHED BLACK STEALTH COATING FROM THE BLADE. THE BLACK COATING STICKS TO BOTH SOFT & HARD TISSUE. IT WAS REPORTED THAT IT LOOKS LIKE BLACK FRAGMENT. IT IS INDICATED THAT THERE WAS NO INJURY OR IMPACT TO THE PATIENT AT THIS TIME AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. ADDITIONAL CLARIFICATION WAS OBTAINED THAT INDICATES THE PATIENT WAS A "20-SOMETHING" YEAR OLD. IT IS NOTED THE SURGEON ENTERED THE ANKLE JOINT ANTERIORLY USING ONE LE-35CUP TO UNCOVER / DISSECT THE LOOSE BONE FRAGMENT THAT WAS SUPPOSED TO BE REMOVED. THE LE-35CUP HAD BEEN IN USE FOR APPROXIMATELY 4 MINUTES WHEN SOME BLACK FRAGMENTS OF THE BLACK COATING DETACHED FROM THE STEALTH BLADE, STICKING TO BOTH BONE AND SOFT TISSUE INSIDE THE JOINT. THE DOCTOR DID PUSH THE BLADE INTO THE TISSUE WITH A LOT OF GREAT FORCE. THE SHAVER BLADE BENT SO HE HAD TO BEND IT BACK TO ITS ORIGINAL CURVE. HE ALSO USED OSCILLATING MODE ON THE S

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 9209069 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.