BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL FOR 4MM SCREWS, DIAM.0.9X46MM, WL5.3M

    MDR report key: 1850325 · Received September 22, 2010

    Report

    Report Number
    8010177-2010-00344
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HBE
    PMA / PMN Number
    K070876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    PER SALES REP THE SURGEON WAS DRILLING A HOLE IN THE RIM PLATE WHEN THE DRILL BIT SNAPPED OFF IN THE PT. THE SURGEON LEFT THE HALF IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWIST DRILL FOR 4MM SCREWS, DIAM.0.9X46MM, WL5.3M INSTRUMENT HBE STRYKER OSTEOSYNTHESIS FREIBURG NA Z8/BB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK