BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SABER DRILL

    MDR report key: 3081074 · Received April 26, 2013

    Report

    Report Number
    0001811755-2013-00929
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, CORROSION WAS FOUND WITHIN THE DEVICE, INCLUDING THE ROTOR ASSEMBLY, WHICH IS A PROBABLE CAUSE OF THE REPORTED OVERHEATING. THE DEVICE WAS REPAIRED BUT NOT YET RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, MULTIPLE DRILLS WERE OVERHEATING, AND THE EVENT OF A BURN WAS REPORTED ON MDR NUMBER 0001811755-2013-00923. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH A DELAY OF WHICH THE USER FACILITY WAS UNABLE TO SPECIFY THE DURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180934 CORE SABER DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 SABER DRILL 5400120000, SN (B)(4)| SABER DRILL 5400120000, SN (B)(4)| SABER DRILL 5400120000, SN (B)(4)