BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8288896 · Received January 30, 2019

    Report

    Report Number
    3005985723-2019-00080
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 10, 2019
    Report Date
    July 16, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT MICS CONTINUES TO RUN AFTER TRIGGER IS RELEASED ON HIP CASE. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION WAS NOT PERFORMED AS THIS WAS A FUNCTIONAL FAILURE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS PERFORMED AND THE DEVICE FAILED THE TEST. PER CASE NUMBER 168721. 1. UNABLE TO REPAIR MICS AS WITH THE NEW CABLE DID NOT FIX THE ISSUE. DISPOSITION - (RETURN TO VENDOR) RTV REASON: STICKY TRIGGER. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT NO K0B9Z AND ACCEPTED INTO FINAL STOCK ON 05/30/2018. NO NON-CONFORMANCE WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, PRODEX LOT NUMBER K0B9Z SHOWS 04 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT ID:1892189, 1895594, 1901491,2046856. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    MICS CONTINUES TO RUN AFTER TRIGGER IS RELEASED ON HIP CASE. CASE TYPE: THA. AS PER THE MPS: CONTINUES TO RUN INSIDE HAPTICS AFTER TRIGGER IS RELEASED. DO NOT KNOW IF IT WILL CONTINUE TO RUN OUTSIDE AND HAPTICS.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    MICS CONTINUES TO RUN AFTER TRIGGER IS RELEASED ON HIP CASE. CASE TYPE: THA. AS PER THE MPS: CONTINUES TO RUN INSIDE HAPTICS AFTER TRIGGER IS RELEASED. DO NOT KNOW IF IT WILL CONTINUE TO RUN OUTSIDE AND HAPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82133 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT 42040518 SN 4204082 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization