BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7920229 · Received September 28, 2018

    Report

    Report Number
    3005985723-2018-00562
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    September 27, 2018
    Report Date
    December 26, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT MICS ATTACHMENT COLLAR BROKE. ALL THREE SCREWS FELL OUT . PRODUCT EVALUATION AND RESULTS: PRODUCT INSPECTION COULD NOT BE PERFORMED AS THE PRODUCT WAS LOST AND NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K08OC AND 23 INCLUDING 4200892 WERE ACCEPTED INTO FINAL STOCK ON 13/9/2017. A REVIEW OF QT17-03-0036 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 K080C, P/N 209063 SHOWS 02 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR: (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 THAT NC 1414517 AND CAPA 1450904 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    MICS ATTACHMENT COLLAR BROKE. ALL THREE SCREWS FELL OUT. SURGICAL DELAY? YES -16-30 MINUTES. CASE TYPE: TKA.

    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

    MICS ATTACHMENT COLLAR BROKE. ALL THREE SCREWS FELL OUT. SURGICAL DELAY? YES: 16-30 MINUTES. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760421 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42020716/4200892 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization