BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH HD LONG ATTACHMENT

    MDR report key: 7242016 · Received February 5, 2018

    Report

    Report Number
    3005985723-2018-00056
    Event Type
    Malfunction
    Date Received
    February 5, 2018
    Date of Event
    January 8, 2018
    Report Date
    April 11, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: THERE IS FRICTION BETWEEN THE BURR AND THE LONG ATTACHMENT AND A BIG NOISE, SO THE LONG ATTACHMENT BECAME VERY HOT. SMOKE WAS REPORTED; NO FLAMES. PKA PROCEDURE. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY REVIEW: NOT PERFORMED AS THE DEVICE IS AN OEM PRODUCT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 110920 S/N (B)(4), SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. THE ANSPACH HD LONG ATTACHMENT HAS A SHORTER LIFE EXPECTANCY THAN THE ANSPACH MOTOR AND IS EXPECTED TO BE REPLACED ONCE WORN. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    THERE IS FRICTION BETWEEN THE BURR AND THE LONG ATTACHMENT AND A BIG NOISE, SO THE LONG ATTACHMENT BECAME VERY HOT. SMOKE WAS REPORTED; NO FLAMES. PKA 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

    THERE IS FRICTION BETWEEN THE BURR AND THE LONG ATTACHMENT AND A BIG NOISE, SO THE LONG ATTACHMENT BECAME VERY HOT. SMOKE WAS REPORTED; NO FLAMES. PKA PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84471 ANSPACH HD LONG ATTACHMENT STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. K49312044621

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization