BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET ACET LP DOME SCREW TI S/TAP Ø6.5X30MM

    MDR report key: 2840820 · Received November 20, 2012

    Report

    Report Number
    3002806535-2012-00347
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. EVALUATION OF THE RETURNED COMPONENT CONFIRMED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF METAL WAS NOTED ON THE THREAD OF A SCREW. THERE WAS NO INJURY TO A PATIENT OR DELAY TO A PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ACET LP DOME SCREW TI S/TAP Ø6.5X30MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 2578552

    Patients

    Seq Age Sex Outcome Treatment
    1