BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKO HANDPIECE

    MDR report key: 13235568 · Received January 12, 2022

    Report

    Report Number
    13235568
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    June 3, 2021
    Report Date
    January 5, 2022
    Manufacturer
    MAKO SURGICAL CORPORATION
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING SURGERY, MAKO HANDLE TRIGGER RELEASE PIECE POPPED OFF. UNSURE WHERE IT WENT, X-RAY WAS CALLED, SURGEON CONTINUED WORKING AND INSTRUCTED X-RAY TECH THAT HE WOULD CALL HER BACK WHEN READY. TEAM CONTINUED WORKING. MAKO REP FOUND PIECE ON FLOOR NEXT TO BED. PIECE FOUND WAS APPROXIMATELY 1 INCH LONG AND HAD APPEARANCE OF HEADLESS NAIL. MAKO REP SAID HE WOULD REORDER REPLACEMENT PIECE FOR MAKO HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802840 MAKO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20075 DA Male