BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED MEDIUM SABER ATTACHMENT

    MDR report key: 1853881 · Received September 7, 2010

    Report

    Report Number
    1811755-2010-01061
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 12, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MFR AND THE COMPLAINT WAS CONFIRMED. BASED ON THE RESULTS OF THE QUALITY INVESTIGATION, THE NOSE BEARINGS WERE SEIZED,DUE TO EXTENSIVE CORROSION. CORROSION WITHIN BEARINGS WILL CAUSE EXCESSIVE FRICTION, WHICH CAN LEAD TO HEAT BEING GENERATED. IMPROPER OR INADEQUATE CLEANING/STERILIZATION TECHNIQUES COULD CONTRIBUTE TO CORROSION OF INTERNAL COMPONENTS WITHIN THIS DEVICE. THE DRILL ATTACHMENT COULD NOT BE REPAIRED AND WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL ATTACHMENT HEATED UP. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITHOUT CAUSING A CLINICALLY SIGNIFICANT DELAY. NO PT OR USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED MEDIUM SABER ATTACHMENT DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO 09222

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK