BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7264592 · Received February 12, 2018

    Report

    Report Number
    3005985723-2018-00067
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 25, 2018
    Report Date
    April 27, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT THE SCREW IN THE HANDPIECE HANDLE WAS LOOSE/FELL OUT. PRODUCT HISTORY REVIEW DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K09D1 AND 23 DEVICES INCLUDING 4201990 WERE ACCEPTED INTO FINAL STOCK ON 05/03/17. A REVIEW OF QT17-05-0017 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K09D1, P/N 209063 SHOWS NO OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. VISUAL INSPECTION VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. THE SCREW WAS OUTSIDE OF THE UNIT. DIMENSIONAL INSPECTION DIMENSIONAL INSPECTION WAS NOT COMPLETED VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. MATERIAL ANALYSIS MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION THE HANDPIECE MOTOR AND ELECTRONICS FUNCTION AS INTENDED. CONCLUSION THE SCREW HOLDS THE HANDLE IN PLACE. IF THE SCREW BACKS OUT THEN THE HANDLE CAN FALL. NC/CAPA HISTORY REVIEW A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NC 1429704 AND CAPA 1452931 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT. TREND #1025.

    Description of Event or Problem · 0

    THE MICS HANDPIECE FELL OFF AFTER ALL CUTS HAD BEEN MADE WHEN THE DOCTOR WAS PUTTING THE ARM BACK INTO THE HOLSTER POSITION. TKA CASE.

    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

    THE MICS HANDPIECE FELL OFF AFTER ALL CUTS HAD BEEN MADE WHEN THE DOCTOR WAS PUTTING THE ARM BACK INTO THE HOLSTER POSITION. TKA CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108085 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4201990 / 42050317

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization