BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVAL SOLID BUR - MEDIUM

    MDR report key: 3022364 · Received March 27, 2013

    Report

    Report Number
    0001811755-2013-00607
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS INDICATE THAT THE PARTICLES WITHIN THE PACK WERE NOT IDENTIFIED DURING THE PACKAGING PROCESS. CORRECTIVE ACTIONS WERE TAKEN TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. IF THE PRODUCT IS RECEIVED, AN EVALUATION WILL BE PERFORMED AND A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, DEBRIS WAS FOUND IN THE INNER PACKAGE. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT, NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, DEBRIS WAS FOUND IN THE INNER PACKAGE. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT, NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125678 OVAL SOLID BUR - MEDIUM BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER INSTRUMENTS-KALAMAZOO 10060017

    Patients

    Seq Age Sex Outcome Treatment
    1