BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE 25.0X1.07X90MM

    MDR report key: 3102378 · Received May 9, 2013

    Report

    Report Number
    0001811755-2013-01070
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 19, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 DURING PREPARATION FOR USE, THE PACKAGING OF 8 DEVICES WOULD NOT OPEN CORRECTLY AND DISINTEGRATED INTO SEVERAL PIECES. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT, NO DELAY AND THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203038 SAGITTAL BLADE 25.0X1.07X90MM BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER INSTRUMENTS-KALAMAZOO 08156017

    Patients

    Seq Age Sex Outcome Treatment
    1