BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASPAR DISTR PIN16MMSTER

    MDR report key: 1147729 · Received August 21, 2008

    Report

    Report Number
    3005673311-2008-00024
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    July 8, 2008
    Report Date
    August 7, 2008
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AESCULAP IMPLANT SYSTEMS (AIS) HAS REQUESTED THE DEVICE AND POST-OP X-RAYS FOR INVESTIGATION. USER FACILITY HAS DEVICE AND IS DETERMINING IF/WHEN IT CAN BE RELEASED FOR EVALUATION. AIS WILL FORWARD THE DEVICE TO THE MANUFACTURING FACILITY UPON RECEIPT.

    Description of Event or Problem · 1

    PLACED A FF905SB WHICH WENT IN FINE. WHEN IT WAS TIME TO TAKE THE DISTRACTION PIN OUT, PLACED SCREWDRIVER ON, STARTED TO UNSCREW IT AND THE PIN BROKE IN HALF (APPROXIMATELY). BOX WAS DISCARDED; THEREFORE, LOT NUMBER IS UNKNOWN. SURGEON DECIDED TO LEAVE THE PIECE. SURGERY WAS DELAYED 30 MINUTES TRYING TO REMOVE THE PIN. PATIENT INJURY WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASPAR DISTR PIN16MMSTER LXH AESCULAP AG & CO. KG FF905SB NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other