BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO GRIP KNEE POINTER

    MDR report key: 4222797 · Received November 4, 2014

    Report

    Report Number
    0001811755-2014-03935
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K022579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WAS DROPPED DURING HANDLING AND THE BALL TIP BROKE OFF UPON GROUND IMPACT. BASED ON THE NATURE OF THE REPORTED EVENT AND THE INFORMATION RECEIVED DURING THE FOLLOW UP, THE EVENT WAS CAUSED BY USE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALL TIP WAS BROKEN OFF OF THE ORTHO GRIP KNEE POINTER AFTER IT WAS DROPPED ON THE GROUND DURING TESTING AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALL TIP WAS BROKEN OFF OF THE ORTHO GRIP KNEE POINTER AFTER IT WAS DROPPED ON THE GROUND DURING TESTING AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707292 ORTHO GRIP KNEE POINTER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1