BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 2936048 · Received January 30, 2013

    Report

    Report Number
    0001811755-2013-00055
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND EVALUATED. (B)(4): DEVICE HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLIANT WAS CONFIRMED DURING THE EVALUATION OF THE DEVICE. IT WAS NOTED THAT FOUND THE INPUT SHAFT GUIDE WAS SEPARATED FROM THE ATTACHMENT AND THE COMPRESSION SPRING AND THE RETAINING RING WERE ALSO MISSING FROM THE DEVICE. IT IS LIKELY THE REPORTED EVENT WAS DUE TO THE RETAINING RING SINCE ONCE THIS COMPONENT IS LOOSE OR MISSING, IT CAN CAUSE THE COMPRESSION SPRING AND INPUT SHAFT GUIDE TO SLIDE OFF THE DRIVESHAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WASHER AND A SPRING CAME OFF THE SAGITTAL SAW ATTACHMENT DURING A PROCEDURE. AN ALTERNATE ATTACHMENT WAS USED TO COMPLETE THAT PROCEDURE, NO ADVERSE EVENT WAS REPORTED, NO CLINICAL SIGNIFICANCE WAS ATTRIBUTED TO THE FEW MINUTES DELAY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WASHER AND A SPRING CAME OFF THE SAGITTAL SAW ATTACHMENT DURING A PROCEDURE. AN ALTERNATE ATTACHMENT WAS USED TO COMPLETE THAT PROCEDURE, NO ADVERSE EVENT WAS REPORTED, NO CLINICAL SIGNIFICANCE WAS ATTRIBUTED TO THE FEW MINUTES DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40405 SAGITTAL SAW ATTACHMENT SAGITTAL SAW ATTACHMENT HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1