BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORIS PST MAKO OFFSET SHELL IMPACTOR

    MDR report key: 6954554 · Received October 17, 2017

    Report

    Report Number
    3005985723-2017-00500
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 19, 2017
    Report Date
    November 3, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE EVENT REPORTED THAT DURING IMPACTION IN A MAKO THA CASE, THE DOCTOR WAS IMPACTING THE CUP AND THE THREADS ON THE IMPACTION HANDLE STRIPED OUT AND THE IMPACTION HANDLE CAME UN-ATTACHED FROM THE CUP. THE CUP WAS IN ITS FINAL POSITION WHEN THIS HAPPENED. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWS THREAD DAMAGE. THREADS WERE BENT AND WORN AWAY IN A SINGLE AREA. SEE ATTACHED FIGURES. FUNCTIONAL INSPECTION CONFIRMED THAT A CUP WOULD NOT THREAD ONTO THE DEVICE. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATE THAT (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 07/27/2016 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW OF COMPLAINTS FOR P/N 212260, L/N 32990 WITHIN THE TRACKWISE DATABASE SHOW NO OTHER COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE FAILURE WAS CONFIRMED. 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.

    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

    DURING A MAKO THA, THE DOCTOR WAS IMPACTING THE CUP. DURING IMPACTION THE THREADS ON THE IMPACTION HANDLE STRIPED OUT AND THE IMPACTION HANDLE CAME UN ATTACHED FROM THE CUP. THE CUP WAS IN ITS FINAL POSITION WHEN THIS HAPPENED.

    Description of Event or Problem · 1

    DURING A MAKO THA, THE DOCTOR WAS IMPACTING THE CUP. DURING IMPACTION THE THREADS ON THE IMPACTION HANDLE STRIPED OUT AND THE IMPACTION HANDLE CAME UN ATTACHED FROM THE CUP. THE CUP WAS IN ITS FINAL POSITION WHEN THIS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736068 RESTORIS PST MAKO OFFSET SHELL IMPACTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 32990

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization