GENESYS MATRYX 239020M5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854016657), received between Aug 22, 2019 and Aug 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 22, 2019Material Fragmentation; Material Fragmentation

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE 239020M5, GENESES INTERFERENCE SCREW, WAS BEING TIGHTENED BY HAND SCREWDRIVER INTO THE BONE TUNNEL, THE SCREW BLEW UP INTO THREE PIECES IN THE BONE TUNNEL. THE TUNNEL WAS REAMED AND TAPPED PRIOR TO THE SCREW BREAKING INTO PIECES. ALL OF THE PIECES WERE NOT REMOVED. THE PART OF THE SCREW THAT WAS FIXATED TO THE TENDON IN THE BONE TUNNEL WAS LEFT IN PLACE. THE OTHER FRAGMENTS WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A SYNTHESE SCREW AND POST. THERE WAS NO PATIENT INJURY AND THERE WAS A DELAY IN SURGICAL TIME DUE TO THE MALFUNCTION BUT THE LENGTH OF TIME WAS NOT REPORTED. THIS REPORT IS BEING RAISED AS DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8922824 ↗