BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH SPEED ROTARY ATTACHMENT

    MDR report key: 9191239 · Received October 15, 2019

    Report

    Report Number
    3005985723-2019-00734
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    October 2, 2019
    Report Date
    March 11, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486021849
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT PIECE IS LEAKING OIL CASE TYPE: PKA (MICS) PATIENT UNDER ANESTHESIA. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS UNAVAILABLE FOR INSPECTION CAPA 2127499 HAS BEEN RAISED FOR THE SAME. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED AND 49 ACCEPTED (INCLUDING SERIAL 4001390) INTO FINAL STOCK ON 06/17/2019 WITH NO REPORTED DISCREPANCIES. REVIEW OF QT 19-06-0080 REVEALED THAT THE NON-CONFORMANCE IS UNRELATED TO THE FAILURE ALLEGED IN THE EVENT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 204990, LOT 40M115490 SHOWS 0 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: 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. H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    PIECE IS LEAKING OIL. CASE TYPE: PKA (MICS). PATIENT UNDER ANESTHESIA.

    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

    PIECE IS LEAKING OIL. CASE TYPE: PKA (MICS). PATIENT UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984437 HIGH SPEED ROTARY ATTACHMENT STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 204990 4001390 00848486021849

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization