BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW/LOCK, END CAPS, THREADED RECON SCREWS, CORTICAL SCREWS,

    MDR report key: 2347762 · Received November 23, 2011

    Report

    Report Number
    0001825034-2011-01061
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Report Date
    October 27, 2011
    Manufacturer
    BIOMET
    Product Code
    HRS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PART # L/N DATE OF MANUFACTURE DATE OF EXPIRATION27845 206540 3/30/11 2/28/2127845 059230 2/11/11 1/31/21 27840 868270 10/22/10 9/30/2027855 206560 3/30/11 2/28/2129207 162674 5/16/05 5/30/1529207 775030 3/31/09 2/28/1929208 311010 12/01/09 11/30/19 29208 350190 12/17/09 11/30/19 14-441280 02226014-444180 88209014-406080 948000 (2) PCS14-406095 94183014-406060 61568014-405050 943730 12/03/10 11/30/2014-405030 UNKNOWN 14-405040 756480 4/19/10 3/31/2014-400424 491980 3/10/10 2/28/2014-405036 20870014-405038 091870 4/06/11 3/31/21CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICES APPEARS TO SHOW EVIDENCE OF USE ERRORS, OR THE REASONS FOR THE ISSUES CANNOT BE DETERMINED DUE TO LACK OF EVENT INFORMATION.

    Description of Event or Problem · 1

    INFORMATION RECEIVED REPORTED DEFORMATION OF SCREW COMPONENTS, FRACTURE OF NAIL AND CORTICAL SCREWS AND DAMAGE TO OTHER COMPONENTS. REPORT DOES NOT INCLUDE INFORMATION ON WHETHER THE ITEMS WERE BEING USED IN A SURGERY OR DEMONSTRATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. IF FURTHER INFORMATION IS RECEIVED, INFORMATION WILL BE REASSESSED FOR REPORTING RESPONSIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREW/LOCK, END CAPS, THREADED RECON SCREWS, CORTICAL SCREWS, PLATE, FIXATION, BONE HRS BIOMET N/A

    Patients

    Seq Age Sex Outcome Treatment
    1