BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7658946 · Received July 3, 2018

    Report

    Report Number
    3005985723-2018-00402
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 6, 2018
    Report Date
    September 28, 2018
    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 THE MICS WAS DIFFICULT TO MANIPULATE DUE TO UNINTENDED MOVEMENT OF THE HANDLE. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K08UF AND 24 INCLUDING (B)(4) WERE ACCEPTED INTO FINAL STOCK ON 01/25/2017. A REVIEW OF QT17-01-0086 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, S/N (B)(4) IN PRODEX LOT K08UF SHOWS 2 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT (B)(4). CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT WILL BE REOPENED. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    WHEN HANDLE IS SIDEWAYS, IT KEEPS POPPING OUT OF PLACE WHEN CUTTING HARDER BONE. 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

    WHEN HANDLE IS SIDEWAYS, IT KEEPS POPPING OUT OF PLACE WHEN CUTTING HARDER BONE. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502460 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4201397 / 42041116 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization