BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED LONG SABER ATTACHMENT

    MDR report key: 2082088 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01420
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. BASED ON THE RESULTS OF THE QUALITY INVESTIGATION, THE BEARINGS WERE HEATING UP DUE TO CONTAMINATION AND DEBRIS. DEBRIS WITHIN BEARINGS WILL CAUSE 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 THEREFORE WAS NOT RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DRILL ATTACHMENT WAS LOUD AND HEATED UP DURING A ROUTINE MAINTENANCE EVALUATION BY THE MANUFACTURER'S FIELD SERVICE TEAM. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT. THERE WAS NO USER INJURY REPORTED AND NO ADVERSE CONSEQUENCES ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED LONG SABER ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO 10302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK