BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED MEDIUM SABER ATTACHMENT

    MDR report key: 1860307 · Received September 23, 2010

    Report

    Report Number
    1811755-2010-01244
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND THE BEARINGS WERE MISSING THE REQUIRED LUBRICANT. IF LUBRICATION IS NOT PRESENT, HEAT WILL BE GENERATED AMONG ROTATING COMPONENTS. PER THE INSTRUCTIONS FOR USE, THE USER FACILITY IS INSTRUCTED TO LUBRICATE THE DEVICE EVERY TWO MONTHS, OR EVERY FORTY STERILIZATION CYCLES (WHICHEVER COMES FIRST). THE DEVICE COULD NOT BE REPAIRED AND WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE EVAL CONDUCTED AT THE MANUFACTURER, THE DRILL ATTACHMENT HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO 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 09335

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK