BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH HD LONG ATTACHMENT

    MDR report key: 6943713 · Received October 12, 2017

    Report

    Report Number
    3005985723-2017-00494
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    October 6, 2017
    Report Date
    January 19, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: THE HD LONG WAS RELEASE BLACK STUFF WHEN IN USE. PKA PROCEDURE, COMPLETED SUCCESSFULLY WITH THE ROBOT. WHILE COMPLETING A PKA SURGERY, THE SURGEON WAS BURRING THE TIBIA WHEN HE NOTICED ¿BLACK STUFF¿ COMING OUT OF THE HD LONG. THE SURGEON WAS ABLE TO CLEAN THE ¿BLACK STUFF¿ OUT OF THE JOINT SO THERE WAS NO PATIENT HARM. THERE WAS NO DELAY IN SURGERY. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION (SEE ATTACHMENTS), NO APPARENT OBSTRUCTIONS WERE OBSERVED AT THE DISTAL END OF THE HD LONG ATTACHMENT. NO OBSERVATION OF DAMAGE OR HANDLING ISSUES WITH THE ATTACHMENT. SCRATCHES ON THE OUTER HOUSING ARE TYPICAL WITH USE OF THE END EFFECTOR USED WITH THE ANSPACH MOTOR. DIMENSIONAL INSPECTION: NOT PERFORMED AS THE ANSPACH HD LONG ATTACHMENT IS AN OEM PRODUCT. TOLERANCES ARE UNKNOWN. FUNCTIONAL INSPECTION: THE BURR WAS ABLE TO BE INSERTED INTO THE HD LONG ATTACHMENT. THE HD LONG ATTACHMENT WITH BURR WAS CONNECTED TO AN ANSPACH MOTOR AND TESTED. THE FAILURE MODE OF VISIBLE BLACK RESIDUE COULD NOT BE REPLICATED. PRODUCT HISTORY REVIEW: NOT PERFORMED AS THE DEVICE IS AN OEM PRODUCT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 110920, LOT NUMBER J31310868006 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE REPORTED FAILURE OF HD LONG ATTACHMENT COULD NOT BE REPRODUCED. THE FAILURE MODE IS NOT CONFIRMED. THE ANSPACH HD LONG ATTACHMENT HAS A SHORTER LIFE EXPECTANCY THAN THE ANSPACH MOTOR AND IS EXPECTED TO BE REPLACED ONCE WORN. CLEANING/MAINTENANCE INSTRUCTIONS ARE INCLUDED WITH THE OEM (ANSPACH) LABELING. 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.

    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 HD LONG WAS RELEASE BLACK STUFF WHEN IN USE. PKA PROCEDURE, COMPLETED SUCCESSFULLY WITH THE ROBOT.

    Description of Event or Problem · 1

    THE HD LONG WAS RELEASE BLACK STUFF WHEN IN USE. PKA PROCEDURE, COMPLETED SUCCESSFULLY WITH THE ROBOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724725 ANSPACH HD LONG ATTACHMENT STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. J31310868006

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization