BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7377706 · Received March 28, 2018

    Report

    Report Number
    3005985723-2018-00206
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    March 23, 2018
    Report Date
    September 7, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE: MICS FELL OF DURING THE CASE. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K0A37 AND 25 INCLUDING 4202728 WERE ACCEPTED INTO FINAL STOCK ON 8/24/17. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K0A37, P/N 209063 LOT K0A37 SHOWS NO OTHER COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION PRODUCT INSPECTION: VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED. THE REPORTED PROBLEM WAS A FUNCTIONAL ISSUE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION REVEALED NO PHYSICAL DAMAGE AND THE PRODUCT FUNCTIONED AS INTENDED. ALL BOLTS AND SCREWS ON THE MICS WERE OBSERVED TO BE INTACT WHEN THE PRODUCT WAS INSPECTED. CONCLUSION: THE ALLEGED FAILURE WAS NOT CONFIRMED. NC/CAPA REVIEW: 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 NC 1429704 AND CAPA 1452931.

    Description of Event or Problem · 0

    THE BOLT ON MICS HANDPIECE BECAME LOOSE AND HANDPIECE FELL OFF INTRA OP. TKA CASE DELAYED 2 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

    THE BOLT ON MICS HANDPIECE BECAME LOOSE AND HANDPIECE FELL OFF INTRA OP. TKA CASE DELAYED 2 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221963 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4202728 / 42040817

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization