BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R/R TPS ELITE LONG ANGLE ATT

    MDR report key: 1983848 · Received January 11, 2011

    Report

    Report Number
    1811755-2011-00063
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 18, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS CONTAINED BY THE MANUFACTURER AND THE DEVICE WAS DISASSEMBLED. FOREIGN DEBRIS WAS FOUND SURROUNDING THE NOSE BEARING, PREVENTING IT FROM ROTATING FREELY. DEBRIS WITHIN BEARINGS WILL CAUSE EXCESSIVE FRICTION, WHICH CAN LEAD TO HEAD BEING GENERATED. 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 DURING TESTING CONDUCTED AT THE MANUFACTURER, THE DRILL ATTACHMENT HEATED UP. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, 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 R/R TPS ELITE LONG ANGLE ATT DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK