GENESYS MATRYX 231035M5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854016893), received between Aug 21, 2020 and Aug 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 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 21, 2020Fracture; Material Fragmentation; Fracture; Material Fragmentation

  CONMED (B)(6) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 231035M5, GENESYS MATRYX SCREW 10X35MM, WAS USED IN AN ACL PROCEDURE ON (B)(6) 2020. THE SCREW BROKE DURING INSERTION. THE SCREW TIP WAS RETRIEVED PER THE FACILITY. THERE WAS A 2-MINUTE DELAY AND ANOTHER OF THE SAME TYPE OF SCREW WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT. ADDITIONAL INFORMATION STATED THAT THE SURGEON WILL OFTEN USE A SCREW 2 SIZES ABOVE REAMED DIAMETER. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435978 ↗