BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_ROBOT ARM

    MDR report key: 17325044 · Received July 14, 2023

    Report

    Report Number
    3005985723-2023-00114
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 20, 2023
    Report Date
    September 22, 2023
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT. AN EVENT REGARDING INACCURATE RESECTION INVOLVING AN UNKNOWN ROBOTIC ARM WAS REPORTED. THE EVENT WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. METHOD & RESULTS -PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED.

    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 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    [DESCRIPTION: DISTAL FEMORAL 1.8MM POSTERIOR CHAMFER: 0.6MM] [RIO REG: 0.28] [RIO VER: 1.2 (BEST OF 3)] [PROBE REG: BLUE 1.0 GREEN 0.8][BONE REG: FEMUR 0.3 TIBIA 0.4] [PIN PLACEMENT: BOTH INTRA INCISIONAL] [BLADE REG VALUE: ANGLE 0.3]. ADDITIONAL INFORMATION: AS FAR AS I CAN REMEMBER THERE WAS NO RED ON SCREEN DURING THIS CASE FOR THE DISTAL FEMORAL CUT. IT WAS SHOWING ALL WHITE. TKA 1.0.

    Description of Event or Problem · 0

    [DESCRIPTION: DISTAL FEMORAL 1.8MM POSTERIOR CHAMFER: 0.6MM] [RIO REG: 0.28] [RIO VER: 1.2 (BEST OF 3)] [PROBE REG: BLUE 1.0 GREEN 0.8][BONE REG: FEMUR 0.3 TIBIA 0.4] [PIN PLACEMENT: BOTH INTRA INCISIONAL] [BLADE REG VALUE: ANGLE 0.3]. ADDITIONAL INFORMATION: AS FAR AS I CAN REMEMBER THERE WAS NO RED ON SCREEN DURING THIS CASE FOR THE DISTAL FEMORAL CUT. IT WAS SHOWING ALL WHITE. TKA 1.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806173 UNKNOWN_ROBOT ARM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other