BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI-DBLE LEAD CORT 5.0X40MM SCR

    MDR report key: 3009462 · Received March 18, 2013

    Report

    Report Number
    0001825034-2013-00634
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BIOMET
    Product Code
    HSB
    PMA / PMN Number
    PK063570
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW WAS RETURNED BUT NO EVALUATION WAS PERFORMED. THE SCREW WAS REPORTED DUE TO INTERVENTION TO REMOVE SCREW. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00633-1 / 00634-1).

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00633 / 00634).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TRAUMA PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, WHILE THE SURGEON WAS ATTEMPTING TO INSERT THE SCREW INTO THE FEMUR THE INSERTER CONNECTOR FRACTURED AND THE SCREW REMAINED IN THE FEMUR. THE SURGEON RETRIEVED THE SCREW BUT AS A RESULT USED A DIFFERENT SCREW AND A SHORTER SCREWDRIVER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112382 TI-DBLE LEAD CORT 5.0X40MM SCR ROD, FIXATION HSB BIOMET N/A 672180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R