BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP END EFFECTOR- VARIABLE ANGLE

    MDR report key: 4671987 · Received April 9, 2015

    Report

    Report Number
    3005985723-2015-00050
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 11, 2015
    Report Date
    March 11, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP#1 SUBMITTED TO CORRECT, BASED ON THE RESULTS OF INVESTIGATION. AN EVENT REGARDING A LOCKING MECHANISM FAILURE WITH THE PARALLEL HIP END EFFECTOR WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS PERFORMED AND THE PARALLEL HIP END EFFECTOR EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW: BASED ON THE DEVICE HISTORY REVIEW THERE WERE NO REPORTED DISCREPANCIES. 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 LOCKING MECHANISM FAILURE OF CATALOG: 206967, SERIAL NUMBER: (B)(4), LOT #: 19060212. RMA #: (B)(4). THERE HAVE BEEN NO OTHER EVENTS FOR THE REFERENCED SERIAL NUMBER OR LOT NUMBER. CONCLUSIONS: THE PARALLEL HIP END EFFECTOR (P/N 206967, L/N 190179) WAS EVALUATED VISUALLY AND FUNCTIONALLY UPON RECEIPT AND THE REPORTED EVENT WAS CONFIRMED. THE PARALLEL HIP END EFFECTOR SHOWED A FAILED LOCKING MECHANISM KNOB WAS BROKEN, WHICH HAS MADE ACTUATING THE LOCKING MECHANISM DIFFICULT.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS PST HIP IMPLANTS. AFTER IMPACTING THE CUP, THE END EFFECTOR WOULD NOT DISENGAGE FROM THE IMPACTOR SHAFT. IT WAS NOTED THAT THE BACK OF THE HANDLE BROKE. THIS DID NOT AFFECT THE CASE AND IT WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS PST HIP IMPLANTS. AFTER IMPACTING THE CUP, THE END EFFECTOR WOULD NOT DISENGAGE FROM THE IMPACTOR SHAFT. IT WAS NOTED THAT THE BACK OF THE HANDLE BROKE. THIS DID NOT AFFECT THE CASE AND IT WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235080 HIP END EFFECTOR- VARIABLE ANGLE STEREOTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP. 9060212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other