BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE ANGLED SAGITAL SAW

    MDR report key: 20540078 · Received October 25, 2024

    Report

    Report Number
    3005985723-2024-00219
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 25, 2024
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032128
    PMA / PMN Number
    K172219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    MAKO ANGLED SAW ATTACHMENT LOCKING MECHANISM IS BROKEN. IT WILL NOT HOLD THE SAW IN PLACE AND AS A RESULT HAS ABOUT 2MM OF TOGGLE IN THE BLADE. THIS INTRODUCES 2MM OF INACCURACY DURING CUTS AND WAS EVIDENT DURING THE CASE. INITIALLY THE SURGEON ALIGNED THE SAW FOR THE DISTAL FEMORAL CUT AND STARTED THE SAW BLADE OFF THE BONE. BEFORE CUTTING THE BONE, THE SURGEON MADE A COMMENT THAT THE SAW SEEMED TO HAVE MORE VIBRATION THAN USUAL SO WE RE CHECKED THE SAW CHECKPOINT WITH THE GREEN PROBE AND IT PASSED. THE SURGEON PERFORMED BOTH ANGLED SAW CUTS AND PROCEEDED TO THE STRAIGHT ATTACHMENT CUTS. WE THEN TRAILED THE FEMUR AND IT WASN'T SITTING FLUSH. I GOT THE SURGEON TO CHECK HIS CUTS WITH THE PLANAR PROBE AND BOTH THE DISTAL AND POSTERIOR CHAMFER WERE OFF BY ABOUT 2MM. WE THEN SWITCHED THE SAW ATTACHMENT AND RECUT BOTH THAT WERE OFF. THE SURGEON NOTICED THE DIFFERENCE IN AMOUNT OF BONE THAT WAS CUT AND WAS SATISFIED WHEN HE RE CHECKED THE CUTS AND TRAILED THE FEMUR AGAIN. UPON EXAMINING THE OLD ATTACHMENT WITH THE SAW ATTACHED, THERE WAS VISIBLE ¿PLAY/TOGGLE¿ WHEN THE SAW WAS ¿LOCKED IN¿. MAKO TKA 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890240 2.7 DEGREE ANGLED SAGITAL SAW ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. LOT 35060624 SN 354428 00848486032128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other