BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 4536107 · Received February 23, 2015

    Report

    Report Number
    3005985723-2015-00021
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 23, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED

    Additional Manufacturer Narrative · 1

    UPON FURTHER FILE REVIEW, THE FOLLOWING SECTIONS REQUIRE CLARIFICATION: THE EVENT WAS INADVERTENTLY DOCUMENTED AS A ADVERSE EVENT, HOWEVER, NO ADVERSE EVENT WAS REPORTED. THE EVENT WAS INADVERTENTLY DOCUMENTED AS REQUIRED INTERVENTION, HOWEVER, NO INTERVENTION WAS REPORTED. THE EVENT OCCURRED INTRAOPERATIVE AND WAS RESOLVED WITHOUT FURTHER INTERVENTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. WHEN THE SURGEON WAS IMPACTING THE TIBIAL BASEPLATE IMPLANT, THE TIP OF THE TIBIAL IMPACTOR BROKE. PIECES OF THE BROKEN INSTRUMENT FELL INTO THE PATIENT WOUND, WERE REMOVED, AND THE WOUND WAS WASHED OUT. THE BREAKAGE DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. WHEN THE SURGEON WAS IMPACTING THE TIBIAL BASEPLATE IMPLANT, THE TIP OF THE TIBIAL IMPACTOR BROKE. PIECES OF THE BROKEN INSTRUMENT FELL INTO THE PATIENT WOUND, WERE REMOVED, AND THE WOUND WAS WASHED OUT. THE BREAKAGE DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. WHEN THE SURGEON WAS IMPACTING THE TIBIAL BASEPLATE IMPLANT, THE TIP OF THE TIBIAL IMPACTOR BROKE. PIECES OF THE BROKEN INSTRUMENT FELL INTO THE PATIENT WOUND, WERE REMOVED, AND THE WOUND WAS WASHED OUT. THE BREAKAGE DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125782 TIBIAL INLAY IMPACTOR HEAD STEROTAXIC DEVICE, ACCESSORY OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention