BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW VARIAX FULL THREAD 3.5MM/L20MM

    MDR report key: 2885324 · Received November 20, 2012

    Report

    Report Number
    8031020-2012-00284
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 13, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K101056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WILL NOT BE RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: 619905 WASHER FOR SCREWS: 2.7/3.5/4.0MM LOT# UNK 628308 ANTERIOR MIDSHAFT PLATE VARIAX CLAVICLE 8 HOLE LOT # UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING SURGEON'S INITIAL USE OF THE CLAVICLE PLATES SYSTEM HE (SURGEON) OPTED TO USE THE OBLONG HOLE IN ONE OF THE ANTERIOR MIDSHAFT PLATES, 8 HOLE, IN ORDER TO ACHIEVE PRELIMINARY PLATE FIXATION SO THAT HE COULD BETTER GAUGE HIS ALIGNMENT AND SCREW HOLE POSITIONING. AFTER HE DRILLED HIS INITIAL HOLE AND BEGAN TO TORQUE THE NON LOCKING SCREW DOWN TO THE PLATE, HE NOTICED THAT ONE LIP OF THE SCREW HEAD WAS FIXATED ON THE PLATE, AND THE OTHER WAS SLIPPING THROUGH THE OBLONG HOLE. THIS OF COURSE CAUSED THE SCREW HEAD TO SLIGHTLY WEAR AND DEFORM AND WE OPTED TO REMOVE THE SCREW. ON THE SECOND ATTEMPT HE REINSERTED A NEW SCREW ALONG WITH A WASHER FROM THE SYSTEM. ONCE AGAIN, APPLYING A SIMILAR AMOUNT OF FORCE, THE SCREW HEAD ENCOUNTERED THE SAME PROBLEM AND ACTUALLY PULLED THE HEAD PARTIALLY THROUGH THE WASHER. THE SURGERY THEN PROCEEDED AS NORMAL. THERE WERE NO APPARENT ADVERSE PATIENT AFFECTS OR REACTIONS AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREW VARIAX FULL THREAD 3.5MM/L20MM IMPLANT HWC STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other