BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER X-L STRAIGHT GUARDED ATT

    MDR report key: 2241643 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03196
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED, WHICH REVEALED CORRODED BEARINGS AND FOREIGN DEBRIS CONTAMINATION. THE PRESENCE OF CORROSION AND DEBRIS CAN LEAD TO INCREASED FRICTION AMONG ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED BY A FIELD SERVICE TECHNICIAN, THE ATTACHMENT OVER-HEATED. 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 SABER X-L STRAIGHT GUARDED ATT ERL STRYKER INSTRUMENTS KALAMAZOO 09120

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK