BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACTION DRILL

    MDR report key: 3132526 · Received May 29, 2013

    Report

    Report Number
    0001811755-2013-01217
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K961970
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION EXPECTED WHEN THE DEVICE IS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPACTION DRILL HEATED UP AND BURNT A PATIENT'S LIP DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE. OINTMENT WAS APPLIED TO THE BURN. THE CUSTOMER REPORTED THAT DURING A FOLLOW-UP VISIT THE PATIENT WAS HEALING WELL BUT THERE COULD BE SOME DISCOLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237511 IMPACTION DRILL INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN IMPACTION BUR GUARD| UNKNOWN BUR