BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3027110 · Received March 29, 2013

    Report

    Report Number
    2530088-2013-00453
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR REVEALED THE HELICAL BLADE COUPLING SCREW WAS MANUFACTURED BY A VENDOR AND WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET ON (B)(4) 2013. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 3/14/2003. 25 PARTS WERE RELEASED TO THE WAREHOUSE ON 3/20/2003.

    Description of Event or Problem · 1

    WHILE MALLETING A HELICAL BLADE INTO A TROCHANTERIC FIXATION NAIL, THE BACK END OF THE COUPLING SCREW BROKE OFF. THERE WAS NO ADVERSE EFFECT ON THE PATIENT. PROCEDURE WAS PROLONGED AN ADDITIONAL 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130891 HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 4529822

    Patients

    Seq Age Sex Outcome Treatment
    1