BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO ARIM - ANCHOR THICKNESS 1 MM ON DISPOSABLE

    MDR report key: 2823903 · Received October 10, 2012

    Report

    Report Number
    8031020-2012-00249
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HTY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    I REC'D CONSIGNMENT STOCK TO CONSIGN AT (B)(6) HOSPITAL. UPON UNPACKING THE STOCK AT THE HOSPITAL THE NUN AND I NOTICED THAT ONE OF THE FOUR ITEMS WE REC'D FROM THE (B)(6) WAREHOUSE HAD SEVERAL SMALL HOLES IN THE PACKAGING AND WAS OBSERVED TO HAVE DIRT ON THE OUTSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO ARIM - ANCHOR THICKNESS 1 MM ON DISPOSABLE IMPLANT HTY STRYKER OSTEOSYNTHESIS SELZACH NA F000373PAAE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other