BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 32MM

    MDR report key: 3183238 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03664
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    PATIENT SUSTAINED A DISTAL TIBIA FRACTURE. DURING AN ORIF DISTAL TIBIA AND FIBULA PROCEDURE, WHILE IMPLANTING AN ANTEROLATERAL PLATE AND SCREWS, ONE OF THE SCREW HEADS BROKE OFF WHILE SURGEON WAS TIGHTENING IT. BROKEN SCREW HEAD WAS RETRIEVED BUT THE SHAFT REMAINS IMPLANTED IN PATIENT. SURGEON OPTED TO FORGO IMPLANTING ANOTHER SCREW IN THAT LOCATION. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282686 3.5MM CORTEX SCREW SELF-TAPPING 32MM SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR