BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MM X 25MM

    MDR report key: 2944166 · Received February 5, 2013

    Report

    Report Number
    0001825034-2013-00229
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 31, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PK934469
    Removal / Correction Number
    1825034-2012-020R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. EVALUATION OF RETURNED DEVICE FOUND IMPLANT TO BE OUT OF DESIGN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE UTILIZING AN INTERFERENCE SCREW ON (B)(6) 2012. WHEN ATTEMPTING TO INSERT THE TIBIA SCREW, THE SURGEON HAD DIFFICULTY GETTING THE SCREW OVER THE GUIDEWIRE. THE TIP OF THE SCREW APPEARED NOT TO BE PERFECTLY ROUND. ANOTHER SCREW WAS OPENED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48917 TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MM X 25MM SCREW, FIXATION HWC BIOMET ORTHOPEDICS N/A 716710

    Patients

    Seq Age Sex Outcome Treatment
    1