BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8064350 · Received November 13, 2018

    Report

    Report Number
    3005985723-2018-00666
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 19, 2018
    Report Date
    December 26, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE HANDLE FELL OFF AFTER COMPLETING ALL THE CUTS AND IT WAS NOTICED THAT THE SCREW BROKE IN HALF. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. ALTHOUGH THE DEVICE WAS NOT RETURNED BUT A REVIEW OF THE PROVIDED PICTURE OF THE DEVICE NOTED THAT THE HANDLE HAS DISASSOCIATED AND THE SCREW INSIDE IT WAS BROKEN. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K09Q7 AND 24 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 06-21-2017. A REVIEW OF QT17-06-0068 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, PRODEX LOT K09Q7 SHOWS 1 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THE RELATED COMPLAINTS IS (B)(4). CONCLUSIONS: 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. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN AN NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS NC 1429704 AND CAPA 1452931. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    HANDLE FELL OFF AFTER COMPLETING ALL THE CUTS AND WHEN I WENT TO SCREW HANDLE BACK ON I NOTICED THE SCREW BROKE IN HALF. CASE TYPE: 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

    HANDLE FELL OFF AFTER "COMPLETETING" ALL THE CUTS AND WHEN I WENT TO SCREW HANDLE BACK ON I NOTICED THE SCREW BROKE IN HALF. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906706 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42040517/4202277 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization