BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI MAXLOCK EXTREME DRIVER

    MDR report key: 3126714 · Received May 20, 2013

    Report

    Report Number
    3005039508-2013-00008
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 21, 2013
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR EVAL. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DRIVER TIP FRACTURED IN THE SCREW HEAD DURING THE PROCESS THE PT EXPERIENCED A FRACTURE OF THE 5TH METATARSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222879 MINI MAXLOCK EXTREME DRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HWC ORTHOHELIX SURGICAL DESIGNS, INC. MXM-056T 2615012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention