BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDGUIDE DRILL, AO, DIA 2.0MM (L = 30MM)

    MDR report key: 2841980 · Received November 14, 2012

    Report

    Report Number
    8010177-2012-00254
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HTW
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER HOUSING OF THE SPEED GUIDE SPINS WHEN THE DRILL IS USED. THE PT'S SOFT TISSUE GOT CAUGHT UP IN THE HOUSING SEVERAL TIMES AND SURGEON HAD TO STOP DRILLING TO RETRACT THE TISSUE AWAY FROM GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDGUIDE DRILL, AO, DIA 2.0MM (L = 30MM) INSTRUMENT HTW STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK