BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2852309 · Received November 20, 2012

    Report

    Report Number
    2852309
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 20, 2012
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS DOING A CORE DECOMPRESSION ON A LEFT HIP AND THE CANNULATED SYNTHES DRILL BITE FRAGMENTED IN THE PATIENT FEMORAL HEAD.======================MANUFACTURER RESPONSE FOR CANNULATED 5.0 SCREW SET, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SCREW, FIXATION, BONE HWC SYNTHES (USA) PRODUCTS LLC * 065637

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR