BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND FLUTED BUR, SOFT TOUCH

    MDR report key: 1571669 · Received December 10, 2009

    Report

    Report Number
    9616696-2009-00253
    Event Type
    Malfunction
    Date Received
    December 10, 2009
    Date of Event
    June 17, 2009
    Report Date
    June 17, 2009
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PARTS WERE RECEIVED AND UPON VISUAL INSPECTION, IT WAS CONFIRMED THEY HAD DISCOLOURATION. FEEDBACK FROM THE ACCOUNT INDICATES THAT THE PARTS WERE WASHED IN DETERGENT PRIOR TO RESTERILISATION. A FULL DOCUMENTATION REVIEW WAS CARRIED OUT, NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THIS ALLEGED EVENT. THE ROOT CAUSE IS UNDETERMINED. THERE IS 3 OTHER PART NUMBERS ASSOCIATED WITH THIS MDR AS FOLLOWS: 5620-010-130, 5620-010-140, 5620-010-160.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE SALES REP, THAT THE ROUND FLUTED BURS WERE HEAVILY OXIDIZED PRIOR TO RE-STERILIZATION BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND FLUTED BUR, SOFT TOUCH DRILLS, BURS, TREPHINES & ACCESSORIES HBF STRYKER IRELAND LTD. 09063017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK