BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8130815 · Received December 4, 2018

    Report

    Report Number
    3005985723-2018-00706
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    November 7, 2018
    Report Date
    February 25, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT BOTH OF THESE HANDPIECES ARE NON-FUNCTIONAL AND NEED TO BE REPLACED AS SOON AS POSSIBLE. THE FIRST MICS (42030818, LOT 4204667) HAS A FAULTY LOCKING MECHANISM WHERE THE SAW ATTACHMENT ATTACHES. THIS ISSUE WAS NOTICED DURING SET UP BEFORE THE CASE STARTED . THE SECOND MICS (42070518, LOT 4204155) STOPPED COMMUNICATING WITH THE SOFTWARE AFTER INITIAL REGISTRATION FOR THE SAME CASE BUT WOULD NOT ACTIVATE BY THE TRIGGER FROM THE BONE RESECTION SCREEN TO LOCK IN AND ALLOW US TO MAKE CUTS. AFTER TRYING TO RE-REGISTER AND RESET THE CUTTER, WE REPLACED THIS HANDPIECE AND THE THIRD HANDPIECE ALLOWED US TO FINISH THE CASE WITH A TOTAL DELAY OF APPROXIMATELY 5 MINUTES. PRODUCT EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K0BPW AND ALL 25 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 08/28/20178. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, PRODEX LOT K0BPW SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: PER (B)(4), PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE ALLEGED FAILURE MODE COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NC (B)(4) AND CAPA 1450904 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    BOTH OF THESE HANDPIECES ARE NON-FUNCTIONAL AND NEED TO BE REPLACED AS SOON AS POSSIBLE. THE FIRST MICS (42030818, LOT 4204667) HAS A FAULTY LOCKING MECHANISM WHERE THE SAW ATTACHMENT ATTACHES. THIS ISSUE WAS NOTICED DURING SET UP BEFORE THE CASE STARTED . THE SECOND MICS (42070518, LOT 4204155) STOPPED COMMUNICATING WITH THE SOFTWARE AFTER INITIAL REGISTRATION FOR THE SAME CASE BUT WOULD NOT ACTIVATE BY THE TRIGGER FROM THE BONE RESECTION SCREEN TO LOCK IN AND ALLOW US TO MAKE CUTS. AFTER TRYING TO RE-REGISTER AND RESET THE CUTTER, WE REPLACED THIS HANDPIECE AND THE THIRD HANDPIECE ALLOWED US TO FINISH THE CASE WITH A TOTAL DELAY OF APPROXIMATELY 5 MINUTES. TKA.

    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

    BOTH OF THESE HANDPIECES ARE NON-FUNCTIONAL AND NEED TO BE REPLACED AS SOON AS POSSIBLE. THE FIRST MICS (42030818, LOT 4204667) HAS A FAULTY LOCKING MECHANISM WHERE THE SAW ATTACHMENT ATTACHES. THIS ISSUE WAS NOTICED DURING SET UP BEFORE THE CASE STARTED . THE SECOND MICS (42070518, LOT 4204155) STOPPED COMMUNICATING WITH THE SOFTWARE AFTER INITIAL REGISTRATION FOR THE SAME CASE BUT WOULD NOT ACTIVATE BY THE TRIGGER FROM THE BONE RESECTION SCREEN TO LOCK IN AND ALLOW US TO MAKE CUTS. AFTER TRYING TO RE-REGISTER AND RESET THE CUTTER, WE REPLACED THIS HANDPIECE AND THE THIRD HANDPIECE ALLOWED US TO FINISH THE CASE WITH A TOTAL DELAY OF APPROXIMATELY 5 MINUTES. TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970977 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42030818/4204667 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization