BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER INSTRUMENT

    MDR report key: 14519953 · Received May 26, 2022

    Report

    Report Number
    0002249697-2022-00772
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 26, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THIS PI IS FOR THE INTRA-OPERATIVE CARDIAC ARREST. AS REPORTED BY COMPLAINT FORM: "BEFORE CASE START WHEN THE SCRUB WAS LOADING THE SAW BLADE, THE STRAIT ATTACHMENT WOULD NOT STAY LOCKED CLOSED, KEEP POPPING UP. THE CASE DID CANCEL BUT ONLY BECAUSE PT CODED ON THE TABLE, NOT BECAUSE OF THE MAKO SYSTEM/INSTRUMENTS. CASE TYPE / APPLICATION: RTKA" SPOKE TO MPS. THE FOLLOWING SEQUENCE OF EVENTS OCCURRED: PRIOR TO THE PATIENT BEING IN THE OPERATING ROOM, THE SAW ATTACHMENT WOULD NOT LOCK THE BLADE. A SECOND ATTACHMENT WAS ABLE TO LOCK THE BLADE. PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED UNDER ANESTHESIA. THE KNEE WAS OPENED AND REGISTERED FOR A MAKO TKA (PLACEMENT OF ARRAYS AND CHECKPOINTS). SURGEON PREFERENCE IS TO MANUALLY PREPARE THE PATELLA PRIOR TO MAKING ANY ROBOTIC CUTS, HAD RESECTED HALF THE PATIENT'S PATELLA WHEN THE PATIENT BEGAN GOING INTO CARDIAC ARREST. POSSIBLE CAUSE OR CONTRIBUTOR FOR CARDIAC ARREST NOT REPORTED TO THE MPS. THE MPS MOVED THE ROBOT OUT OF THE WAY. CHECKPOINTS AND ARRAYS WERE REMOVED, PATIENT CLOSED, ATROPINE ADMINISTERED, AND A NURSE PERFORMED CHEST COMPRESSIONS AS THE ANESTHESIOLOGIST BROUGHT IN A CRASH CART. WHEN THE MPS LEFT THE OPERATING ROOM, THE PATIENT WAS IN STABLE CONDITION AND WAS BEING PREPARED TO BE TRANSFERRED TO THE ICU. MPS WILL ADVISE OF ANY UPDATES TO PATIENT STATUS. OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664755 UNKNOWN STRYKER INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization