BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CANNULATED SCREW PARTIALLY THREADED/68MM

    MDR report key: 2963108 · Received February 15, 2013

    Report

    Report Number
    1719045-2013-00328
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K963172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(6). : 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. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A NON UNION PROCEDURE OF THE DISTAL HUMERUS: AS SURGEON WAS INSERTING THE THREADED GUIDE WIRE IT BROKE. THE BROKEN PIECE WAS NOT RETRIEVED. SURGEON IMPLANTED A CANNULATED SCREW AND DETERMINED HE WOULD IMPLANT A SHORTER SCREW INSTEAD. AFTER REMOVING THE CANNULATED SCREW THE SCREW WAS BENT. THE SURGEON NOTED THAT THE PATIENT HAD VERY STRONG BONE WHICH MAY HAVE CONTRIBUTED TO THE GUIDE BREAKING AND THE SCREW BENDING. THE SURGERY WAS PROLONGED BY AN ADDITIONAL 15 MINUTES. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67975 4.5MM CANNULATED SCREW PARTIALLY THREADED/68MM CANNULATED SCREW PARTIALLY THREADED HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR