BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH HD LONG ATTACHMENT

    MDR report key: 6393242 · Received March 9, 2017

    Report

    Report Number
    3005985723-2017-00116
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    March 6, 2017
    Report Date
    June 2, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE EVENT REPORTED THAT BLACK FLUID WAS SEEN LEAKING FROM AN ANSPACH HD LONG ATTACHMENT DURING BURRING AND HAD TO BE SWAPPED OUT DURING A CASE. A DELAY OF 2 MINS OCCURRED. DEVICE EVALUATION AND RESULTS: UNABLE TO PERFORM AS THE PRODUCT WAS NOT RETURNED. DEVICE HISTORY REVIEW: NOT PERFORMED AS THE ANSPACH HD LONG ATTACHMENT IS AN OEM PRODUCT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 110920, S/N (B)(4) SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: 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: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE SURGEON SAW DARK FLUID COMING FROM THE HD ATTACHMENT AS HE WAS BURRING THE FEMUR. HE SWAPPED IT OUT AND SUCCESSFULLY FINISH CASE.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE SURGEON SAW DARK FLUID COMING FROM THE HD ATTACHMENT AS HE WAS BURRING THE FEMUR. HE SWAPPED IT OUT AND SUCCESSFULLY FINISH CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174816 ANSPACH HD LONG ATTACHMENT STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. SNJ44311089223

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization