BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCREWDRIVER SHAFT SHORT, NON-CANNULATED, 2.5MM HEX

    MDR report key: 1083576 · Received July 24, 2008

    Report

    Report Number
    1220246-2008-00138
    Event Type
    Other
    Date Received
    July 24, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY COULD NOT BE REVIEWED AND THE MANUFACTURING DATE WAS NOT DETERMINED. THE CAUSE OF THE COMPLAINANT'S EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE OFF IN THE PT'S KNEE DURING SURGERY. THE TIP WAS RETRIEVED, HOWEVER, THE SURGERY WAS DELAYED OVER 30 MINUTES. NO FURTHER PT INFO IS AVAILABLE AND NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER SHAFT SHORT, NON-CANNULATED, 2.5MM HEX DRIVER HXX ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other