BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR, VARIABLE ANGLE

    MDR report key: 6155666 · Received December 8, 2016

    Report

    Report Number
    3005985723-2016-00428
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    December 7, 2016
    Report Date
    January 17, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    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

    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. REPORTED EVENT: THE HIP END EFFECTOR WAS WORKING FINE THROUGH REGISTRATION, HOWEVER, JUST PRIOR TO REAMING, THE SURGEON GRABBED THE HIP END EFFECTOR AND TRIED SLIDING THE OFFSET REAMER HANDLE OVER THE SLIDING MECHANISM ON THE BACK. IT WAS THEN THAT THE PLATFORM ON THE END EFFECTOR FELL OUT. I¿M ATTACHING PICTURES OF BROKEN END EFFECTOR. THE SURGEON REQUESTED TO CONVERT TO A MANUAL THA, WITH ABOUT A THREE MIN. DELAY. SURGEON WAS HAPPY WITH POST-OPERATIVE X-RAYS. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION THE VARIABLE HIP END EFFECTOR SHOWED A FAILED LOCKING MECHANISM. SPECIFICALLY THE LOCKING MECHANISM KNOB WAS BROKEN AND OXIDATION WAS OBSERVED IN THE SUBASSEMBLY, WHICH HAS MADE ACTUATING THE LOCKING MECHANISM DIFFICULT. THERE ARE CRACKS ALONG THE NOTCHES OF THE VARIOUS ANGLES IN THE FRONT OF THE END EFFECTOR. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED, VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT COMPLETED, VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND INSPECTED ON 04-05-2016. (B)(4) WERE ACCEPTED WITH NO REPORTED DISCREPANCIES, THIS INCLUDES THE RETURNED DEVICE. (B)(4) WAS DISPOSITIONED ACCORDING TO QT16-04-0015. ADDITIONALLY, THE INSPECTION RECORD CONFIRMS THAT THE CERTIFICATE OF CONFORMANCE FOR ASSEMBLY WAS PRESENT AND ACCURATE FOR ALL TOP AND SUBASSEMBLY COMPONENTS. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION, THE CATSWEB AND TRACKWISE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING THE VARIABLE HIP END EFFECTOR, FAILED LOCKING MECHANISM. THERE HAVE BEEN NO OTHER EVENTS FOR THE REFERENCED SERIAL NUMBER. THERE HAS BEEN 6 EVENTS REFERENCED FOR THE LOT NUMBER. PRS # (B)(4) - WERE FOUND TO BE FROM THE SAME LOT AS THE PART IN THIS COMPLAINT. THE PARTS FROM PRS # (B)(4) THE SAME FAILURE. CONCLUSIONS: FAILURE CONFIRMED. 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 · 1

    THE PATIENT WAS PERFORMING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WHEN THE PLATFORM ON THE END EFFECTOR FELL OUT. THE SURGEON REQUESTED TO CONVERT TO A MANUAL THA.

    Description of Event or Problem · 1

    THE PATIENT WAS PERFORMING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WHEN THE PLATFORM ON THE END EFFECTOR FELL OUT. THE SURGEON REQUESTED TO CONVERT TO A MANUAL THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806712 HIP END EFFECTOR, VARIABLE ANGLE STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization