BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1033398 · Received March 25, 2008

    Report

    Report Number
    1825034-2008-00085
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    January 11, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. A MANDATORY MEDWATCH REPORT WAS RE'CD ON FEBRUARY 28, 2008 FROM THE USER FACILITY. THE USER FACILITY STATES THAT DRILL BITS WERE GIVEN TO SALES REP. TO DATE, DEVICES HAVE NOT BEEN RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TOTAL HIP PROCEDURE IN 2008, TWO (2) DRILL BITS BROKE WHILE IN USE. FRACTURED PORTION OF DRILL BITS WERE RETRIEVED AND THERE WAS NO ADVERSE OUTCOME TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK HTW BIOMET, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R