BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8770985 · Received July 9, 2019

    Report

    Report Number
    3005985723-2019-00503
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 26, 2019
    Report Date
    September 9, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: IT WAS REPORTED PART OF LOCKING MECHANISM FROM HANDLE BROKE, MAKING IT DIFFICULT FOR SURGEON TO LOCK IN PLACE. PRODUCT EVALUATION AND RESULTS: PRODUCT INSPECTION COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT: K0AER AND 21 EXCLUDING 4203002 WERE ACCEPTED INTO FINAL STOCK ON 11/02/2017. A REVIEW OF QT 17-11-0002 REVEALED THAT S/N: (B)(6) WAS REJECTED FOR MOTOR SPEED AUDIBLY RAMPS UP AND DOWN CONTINUOUSLY WITHOUT INTERRUPTION. THIS UNIT WERE RE-INSPECTED AND WERE ACCEPTED INTO FINAL STOCK ON 09/20/2018. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N: 209063, S/N: (B)(6) IN PRODEX LOT: K0AER SHOWS NO ADDITIONAL COMPLAINT(S) 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: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT THERE HAVE BEEN NO NC¿S ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    PART OF LOCKING MECHANISM FROM HANDLE BROKE, MAKING IT DIFFICULT FOR SURGEON TO LOCK IN PLACE. CASE TYPE: TKA.

    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

    PART OF LOCKING MECHANISM FROM HANDLE BROKE, MAKING IT DIFFICULT FOR SURGEON TO LOCK IN PLACE. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566003 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42031017 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization