BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8065426 · Received November 13, 2018

    Report

    Report Number
    3005985723-2018-00669
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 31, 2018
    Report Date
    January 15, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE ATTACHMENT WERE VERY DIFFICULT TO FIT AND A BROKEN SCREW FELL FROM THE MICS. ADDITIONALLY IT WAS REPORTED THAT THE SCREWS WERE LOOSE IN THE SAME PLACE IN ALL THE MICS THAT THE HOSPITAL HAD IN THEIR POSSESSION. NOT PERFORMED AS THE PRODUCT WAS LOST AND HENCE WAS NOT AVAILABLE FOR EVALUATION. ALTHOUGH THE PRODUCT WAS LOST BUT A REVIEW OF THE PROVIDED PICTURE OF THE DEVICE NOTED THAT ONE OF THE SCREWS AT THE BOTTOM END OF THE MICS'S LOCKING MECHANISM WAS MISSING.(REFER ATTACHED PICTURES IN INTAKE TAB) DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K09GT AND 24 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 5/8/2017. A REVIEW OF QT17-05-0034 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. A REVIEW OF COMPLAINTS RELATED TO P/N 209063, PRODEX LOT K09GT SHOWS 2 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT (B)(4). . THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE REOPENED. A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NC 1414517 AND CAPA 1450904 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    END USER HAS REPORTED THAT DURING THE OPERATION (THA) WHEN THE STAFF OF THE OPERATING ROOM. TRIED TO FIT THE ATTACHMENT TO THE MICS, THE ATTACHMENT FIT VERY DIFFICULT. THE DOCTOR USED THE MICS WITHOUT ANY PROBLEM BUT WHEN THE STAFF PUT OUT THE MICS ATTACHMENT, A BROKEN SCREW FELL FROM THE MICS, PICTURES ATTACHED INTO THE "INTAKE FORM". AFTER THE PROCEDURE, THEY HAVE INSPECTED THE BROKEN MICS AND AFTER THEY MADE INSPECTIONS TO ALL OF THE MICS HEADPIECES THAT THE HOSPITAL HAS IN THEIR POSSESSION, THEY FOUND OUT THAT ALL THE SCREWS WERE LOOSE IN THE SAME PLACE (SOME SCREWS WERE LOOSER THAN THE OTHERS). THEY STATE THAT FOR ALL THE OTHER MICS, THEY WILL NEED INSTRUCTIONS ON HOW TO SECURE THE SCREWS PROPERLY (WHAT TYPE OF LOCTITE THEY SHOULD USE TO THE THREADS OF THE SCREWS).

    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

    END USER HAS REPORTED THAT DURING THE OPERATION (THA) WHEN THE STAFF OF THE OPERATING ROOM TRIED TO FIT THE ATTACHMENT TO THE MICS, THE ATTACHMENT FIT VERY DIFFICULT. THE DOCTOR USED THE MICS WITHOUT ANY PROBLEM BUT WHEN THE STAFF PUT OUT THE MICS ATTACHMENT, A BROKEN SCREW FELL FROM THE MICS; PICTURES ATTACHED INTO THE "INTAKE FORM". AFTER THE PROCEDURE, THEY HAVE INSPECTED THE BROKEN MICS AND AFTER THEY MADE INSPECTIONS TO ALL OF THE MICS HEADPIECES THAT THE HOSPITAL HAS IN THEIR POSSESSION, THEY FOUND OUT THAT ALL THE SCREWS WERE LOOSE IN THE SAME PLACE (SOME SCREWS WERE LOOSER THAN THE OTHERS). THEY STATE THAT FOR ALL THE OTHER MICS, THEY WILL NEED INSTRUCTIONS ON HOW TO SECURE THE SCREWS PROPERLY (WHAT TYPE OF LOCTITE THEY SHOULD USE TO THE THREADS OF THE SCREWS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906310 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4202112 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization