INSTRUMENT 6541-2-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327240924), received between Apr 25, 2022 and Aug 31, 2024 — classified as 2 injuries.

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.

• InjuryAug 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INCIDENT WAS DURING A MAKO LEFT TKA PROCEDURE, ALTHOUGH MAY NOT BE DIRECTLY LINKED TO STRYKER KIT AS THERE ARE MANY FACTORS THAT COULD HAVE CAUSED IT, SUCH AS SCLEROTIC BONE QUALITY. A SURGEON HAD USED INTRA-INCISIONAL 4.0MM TIBIAL PINS, PLACED ABOUT 4-5CM BELOW THE PLATEAU AS RECOMMENDED. THE CASE PROCEEDED AS EXPECTED UNTIL THE TIBIAL PINS WERE REMOVED, AND THE TIBIAL KEEL PUNCH WAS USED TO PREPARE THE TIBIA FOR AN IMPLANT. WHILST IMPACTING THE KEEL PUNCH, THE TIBIA FRACTURED THROUGH BOTH HOLES IN WHICH THE PINS HAD PREVIOUSLY BEEN, AND THEREFORE A PROXIMAL TIBIAL PLATE WAS REQUIRED TO BE USED AS WELL AS INTRA-OPERATIVE X-RAYING IN ORDER TO GET THE CORRECT PLATE PLACEMENT. THIS PATIENT WAS STILL ABLE TO BE DISCHARGED AS A DAY CASE AS FAR AS I AM AWARE HOWEVER THEY WERE PLANNED FOR A STANDARD MAKO PS TKA WITH A PRIMARY BASEPLATE AND ENDED UP WITH A MAKO PS TKA WITH UNIVERSAL BASEPLATE AND PROXIMAL TIBIAL PLATE. TOURNIQUET WAS USED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20114671 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDIAL TIBIAL FRACTURE OCCURRED DURING THE USE OF A KEEL PUNCH ON THE TIBIA.

  Patient problems: Bone Fracture(s)

  MAUDE report 14194165 ↗