BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7314026 · Received March 5, 2018

    Report

    Report Number
    3005985723-2018-00112
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    February 11, 2018
    Report Date
    May 24, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT THE HANDLE AND SCREW FELL OFF FROM THE MICS DURING THE CASE 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 K09V6 AND 25 INCLUDING 4202457 WERE REJECTED ON 7/12/2017 FOR COC . A REVIEW OF QT17-07-0025 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. ALL PARTS WERE ACCEPTED 7/13/2017. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, L/N K09V6 SHOWS NO ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. 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: 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 · 1

    MICS HANDPIECE: THE GRAY EXTERIOR HANDLE AND SCREW FELL OFF OF HANDLE DURING TIBIAL CUT. BOTH SCREW AND HANDLE WERE RECOVERED, NO PATIENT HARM. TKA PROCEDURE.

    Description of Event or Problem · 1

    MICS HANDPIECE: THE GRAY EXTERIOR HANDLE AND SCREW FELL OFF OF HANDLE DURING TIBIAL CUT. BOTH SCREW AND HANDLE WERE RECOVERED, NO PATIENT HARM. TKA PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157137 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4202451 / 42060617

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization