BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT, SM (HAND)

    MDR report key: 1961198 · Received December 21, 2010

    Report

    Report Number
    2249697-2010-01839
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "WHEN SURGEON WAS DRILLING THE HOLES, THE DRILL BIT BROKE OFF INSIDE OF THE UNIVERSAL DRILL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT, SM (HAND) INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other