BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J6 ARM FOR HIP WITH QD

    MDR report key: 7888784 · Received September 19, 2018

    Report

    Report Number
    3005985723-2018-00536
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 28, 2018
    Report Date
    December 5, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: "THE MAKO ROBOTIC ARM FAILED DURING SURGERY, JOINT ERROR HAPPENED HALF WAY WHEN BURRING THE FERMORAL SIDE. AFTER SURGERY WE FOUND THE P/N 203486 J6 GLASS IS LOOSE AND THE SYSTEM J6 CANNOT HOMING." DEVICE EVALUATION AND RESULTS: THE J6 ARM SUBASSEMBLY(207557) REPLACED AND ALL TESTING WAS COMPLETED. PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE NO DATA DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON NO DATA. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW : A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 207557 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    THE MAKO ROBOTIC ARM FAILED DURING SURGERY, JOINT ERROR HAPPENED HALF WAY WHEN BURRING THE FERMORAL SIDE. AFTER SURGERY WE FOUND THE P/N 203486 J6 GLASS IS LOOSE AND THE SYSTEM J6 CANNOT HOMING; PKA RESOLUTION: J6 SUBASSEMBLY WAS REPLACED UPDATE: PATIENT WAS UNDER ANESTHESIA. CASE WAS SWITCHED TO MANUAL. DELAY WAS >30 MINS.

    Additional Manufacturer Narrative · 1

    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 · 1

    THE MAKO ROBOTIC ARM FAILED DURING SURGERY, JOINT ERROR HAPPENED HALF WAY WHEN BURRING THE FEMORAL SIDE. AFTER SURGERY WE FOUND THE P/N 203486 J6 GLASS IS LOOSE AND THE SYSTEM J6 CANNOT HOMING; PKA. RESOLUTION: J6 SUBASSEMBLY WAS REPLACED. UPDATE: PATIENT WAS UNDER ANESTHESIA. CASE WAS SWITCHED TO MANUAL. DELAY WAS > 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730513 J6 ARM FOR HIP WITH QD STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 183271-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization