BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9397063 · Received December 2, 2019

    Report

    Report Number
    3005985723-2019-00893
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 5, 2019
    Report Date
    March 16, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: THE SCREW GOT LOOSE AND THE GRIP COVER CAME OFF. A BACKUP DEVICE WAS USED. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS UNAVAILABLE FOR INSPECTION CAPA 2127499 HAS BEEN RAISED FOR THE SAME. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER 42070319 AND 24 WERE ACCEPTED INTO FINAL STOCK ON 04/13/2019. A REVIEW OF QT19-04-0054 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, L/N: 42070319 , SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE ALLEGED FAILURE MODE COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NCS OR CAPAS ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE SCREW GOT LOOSE AND THE GRIP COVER CAME OFF. A BACKUP DEVICE WAS USED.

    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

    THE SCREW GOT LOOSE AND THE GRIP COVER CAME OFF. A BACKUP DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192306 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 4206347 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization