My Knee Tibial Cutting Blocks 4.1034SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030848209), received between Apr 12, 2024 and Apr 12, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (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.

• MalfunctionApr 12, 2024Positioning Problem; Positioning Problem

  THE SURGEON WAS NOT HAPPY WITH THE TIBIAL CUT PERFORMED WITH THE MYKNEE CUTTING BLOCKS. HE ALREADY DISCOVERED IT AFTER THE INITIAL TIBIAL CUT BUT WANTED TO PERFORM THE FEMORAL DISTAL CUT FIRST ANYWAY. THE GAP WAS TOO TIGHT, SO HE DECIDED TO RECUT THE TIBIA. NO CALIPER WAS USED. THE SURGEON PERFORMED 3 TIMES THE TIBIAL RECUT IN ORDER TO OBTAIN THE SUFFICIENT FLEXION GAP. DELAY 30/40 MINUTES (TOTAL SURGERY TIME ABOUT 2 HOURS AND 30 MIN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094640 ↗