BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7328086 · Received March 9, 2018

    Report

    Report Number
    3005985723-2018-00163
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 9, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE MICS FAILED IN A THA CASE. PRODUCT EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. NC 1694916 HAS BEEN INITIATED IN REGARDS TO MISSING PRODUCT. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K09GW AND 22 INCLUDING 4202166 WERE ACCEPTED INTO FINAL STOCK ON 05/10/2017. A REVIEW OF QT17-05-0038 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K09GW, P/N 209063 SHOWS 05 OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINTS ARE (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 NC1414517 AND CAPA 1450904. H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    BROKEN LOCKING COLLAR ON MICS. THA PROCEDURE DELAYED APPROXIMATELY 5 MINUTES.

    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

    BROKEN LOCKING COLLAR ON MICS. THA PROCEDURE DELAYED APPROXIMATELY 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169715 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4202166 / 42060417

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization