BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE

    MDR report key: 3083190 · Received April 29, 2013

    Report

    Report Number
    0001811755-2013-00939
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS VISUALLY CONFIRMED THAT THE PACKAGING MATERIAL WAS BRITTLE. THE LABEL FOR THIS DEVICE HAS A SYMBOL INDICATING "STERILE ONLY IF PACKAGE IS UNOPENED AND UNDAMAGED". AN ALTERNATIVE PACKAGING MATERIAL HAS SINCE BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGE WAS TEARING WHILE OPENING. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AND THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185695 SAGITTAL BLADE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS-KALAMAZOO 08198017

    Patients

    Seq Age Sex Outcome Treatment
    1