BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3132591 · Received May 29, 2013

    Report

    Report Number
    2530088-2013-00808
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, DURING A SHORT TROCHANTERIC FIXATION NAIL SYSTEM PROCEDURE, THE KNOB AT THE END OF THE HELICAL BLADE CONNECTING SCREW BROKE OFF WHILE IMPACTING THE HELICAL BLADE INTO THE FEMORAL HEAD/NECK. THE HELICAL BLADE WAS IMPACTED TO THE APPROPRIATE DEPTH AND THE REMAINDER OF THE CONNECTING SCREW WAS DISENGAGED FROM THE HELICAL BLADE USING A 3.5MM HEX SCREWDRIVER. DISTAL SCREW WAS PLACED AND THE PATIENT CLOSED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234182 HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 4984966

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR