BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE STRAIGHT SAGITAL SAW

    MDR report key: 9694881 · Received February 11, 2020

    Report

    Report Number
    3005985723-2020-00080
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 17, 2020
    Report Date
    April 13, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032111
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED ISSUE - A LOT OF BLACK FLUID IS COMING FROM THE ATTACHMENT. DISCOVERY MADE IN STERILE PROCESSING. NO ASSOCIATED PROCEDURE. PRODUCT INSPECTION ¿ VISUAL INSPECTION OF CATALOG # 212186, LOT/SERIAL # (B)(6) CONFIRMED THE PRESENCE OF BLACK FLUID COMING FROM THE ATTACHMENT. PRODUCT HISTORY REVIEW - REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 04/29/2016. A REVIEW OF QT 16-06-0053 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW ¿ A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212186, LOT NUMBER 35010516 SHOWS 00 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. NC/CAPA HISTORY REVIEW - A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. CONCLUSION - THE EVENT WAS CONFIRMED. PER D03391, PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED, AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    A LOT OF BLACK FLUID IS COMING FROM THE ATTACHMENT. DISCOVERY MADE IN STERILE PROCESSING. NO ASSOCIATED PROCEDURE.

    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

    A LOT OF BLACK FLUID IS COMING FROM THE ATTACHMENT. DISCOVERY MADE IN STERILE PROCESSING. NO ASSOCIATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158414 2.7 DEGREE STRAIGHT SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 212186 35010516 00848486032111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization