Knee Instruments 11.00008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030842733), received between Mar 20, 2019 and Mar 20, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 20, 2019Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY KNEE SURGERY AND WHILE SIZING THE FEMUR, THE SMOOTH PIN BEGAN TO DISINTEGRATE AND BECAME WEDGED INSIDE THE FEMORAL SIZING GUIDE. IT IS UNKNOWN IF ANY METAL SHAVINGS FROM THE PIN FELL INSIDE OF THE PATIENT. THE SURGEON ALREADY HAD TWO PINS PLACED INTO THE SIZING GUIDE AND WAS ABLE TO SLIDE THE CUTTING BLOCK ONTO THE PINS AND SIZE THE FEMUR. THIS ISSUE CAUSED A 2-MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A MOTORIZED INSTRUMENT WAS USED TO INSERT THE PIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8436838 ↗