Knee Instruments 11.00004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030877377), received between Jan 16, 2019 and Jan 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2019Break; Material Fragmentation

  DURING THE PRIMARY KNEE SURGERY, AND WHILE THE SURGEON WAS REMOVING THE IM ROD AND POSITIONING THE DISTAL FEMORAL CUTTING GUIDE, THE PLASTIC SLEEVE OF THE INSTRUMENT BROKE. THE SURGEON HAD TO USE AN EXCESSIVE AMOUNT OF FORCE TO REMOVE THE IM ROD AND NO DEFECTS WERE OBSERVED IN THE IM ROD PRIOR TO INSERTION. FRAGMENTS FROM THE PLASTIC SLEEVE WERE LEFT IN THE PATIENT'S INTER-MEDULLARY CANAL AND THE SURGEON WAS UNABLE TO RECOVER THE FRAGMENTS. ONE FRAGMENT WAS 5CM IN LENGTH. THERE WAS A 35 MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8260589 ↗
• MalfunctionJan 16, 2019Break; Device Fell

  DURING THE PRIMARY KNEE SURGERY, THE PLASTIC SLEEVE ON THE IM ROD BROKE WHILE THE SURGEON WAS PREPARING TO PERFORM THE DISTAL CUT ON THE FEMUR. A PIECE OF PLASTIC FELL INTO THE PATIENT'S FEMORAL CANAL AND THE SURGEON WAS UNABLE TO RETRIEVE IT. THERE WAS A TEN MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8253139 ↗