BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 38MM

    MDR report key: 3838895 · Received May 29, 2014

    Report

    Report Number
    2520274-2014-11641
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Report Date
    May 8, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: KTT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CORTEX SCREW BROKE DURING SURGERY. THE SURGEON WAS TREATING A FEMUR FRACTURE AND WHILE IMPLANTING THE CORTEX SCREW IN THE LEFT FEMUR, THE SCREW HEAD BROKE OFF. THE HEAD WAS RETRIEVED BUT THE SHAFT REMAINS IN THE PATIENT¿S BONE. THERE WAS NO DELAY IN SURGERY AND NO PATIENT ADVERSE EVENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316587 4.5MM CORTEX SCREW SELF-TAPPING 38MM SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR