INSTRUMENT 6541-2-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327240986), received between Mar 12, 2024 and Mar 12, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction 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 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.

• InjuryMar 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A LEFT TOTAL KNEE REPLACEMENT DURING THE KEEL PUNCH PART OF THE SURGERY THE TIBIA SPLIT. ALL INSTRUMENTATION WAS PUT TOGETHER CORRECTLY. THE GUIDE TOWER WAS CORRECT, THE KEEL PUNCH WAS CORRECT AND THE BASEPLATE WAS CORRECT. CASE WENT LONGER THAN USUAL. THE SURGEON DIDN'T SAY ANYTHING NEGATIVE, JUST WANTED TO REPORT THIS. ADDITIONAL INFO RECEIVED 14-FEB-2024, "THE PROCEDURE WAS A PRIMARY IMPLANTATION OF STRYKER IMPLANTS. KEEL PUNCH IS THE INSTRUMENT USED WHEN THE TIBIA SPLIT. THE SPECIFIC KEEP PUNCH WAS ONE OF THE ONES FOUND IN OUR MIS 3-6 FEMORAL AND TIBIA PREP TRAY. I WOULDN'T SAY IT WAS TOO SEVERE, BUT THE SPLIT WAS BIG ENOUGH TO NEED 2 SCREWS. SCREWS WERE USED TO ADDRESS THE SPLIT BONE."

  Patient problems: Bone Fracture(s)

  MAUDE report 18887264 ↗