BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANCELLOUS BONE SCREW FULLY THREADED/36MM

    MDR report key: 2870560 · Received December 12, 2012

    Report

    Report Number
    1719045-2012-01349
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DURING A TIBIAL TUBERCLE OSTEOTOMY INTERNAL FIXATION PROCEDURE, THE SCREW TIP BROKE OFF. THE TIP OF THE SCREW WAS NOT RETRIEVED AND WAS LEFT IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/36MM CANCELLOUS BONE SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR