BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J6 ARM FOR HIP WITH QD

    MDR report key: 5766143 · Received July 1, 2016

    Report

    Report Number
    3005985723-2016-00209
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 7, 2016
    Report Date
    June 7, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE WAS CONFIRMED TO BE A J6 ARM FOR HIP WITH QD, P/N 207557, LOT ROB295. DEVICE EVALUATION AND RESULTS: REVIEW OF THE DHR INDICATES THAT ROB259, WHICH INCLUDED THE ALLEGEDLY FAILING COMPONENT, WAS COMPLETED AND ACCEPTED INTO STOCK ON 7/31/2013. DEVICE HISTORY REVIEW: ACCORDING TO GSP CASE (B)(4), THE FIELD SERVICE ENGINEER CONFIRMED THE FAILURE, FINDING THAT THE J6 ENCODER HAD COME LOOSE FROM ITS MOUNT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO THE J6 ARM SHOWS 5 ADDITIONAL COMPLAINTS SINCE 2014 RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 207557 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST (B)(4). CONCLUSIONS: THE FAILURE WAS CONFIRMED BY THE FSE. 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 · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). THE SURGEON EXPERIENCED A JOINT INCONSISTENT ANGLE ERROR DURING IMPACTION, THEY WERE UNABLE TO HOME THE SYSTEM AFTER RESTARTING AND THE CASE WAS CONVERTED TO MANUAL. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). THE SURGEON EXPERIENCED A JOINT INCONSISTENT ANGLE ERROR DURING IMPACTION, THEY WERE UNABLE TO HOME THE SYSTEM AFTER RESTARTING AND THE CASE WAS CONVERTED TO MANUAL. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420718 J6 ARM FOR HIP WITH QD STEREOTACTIC DEVICE, ROBOTIC OLO MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other