BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 2120379 · Received May 26, 2011

    Report

    Report Number
    8030965-2011-00257
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 13, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. SYNTHES IS UNABLE TO DETERMINE MFG SITE OR MFG DATE WITHOUT A PART NUMBER OR A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION COULD NOT BE CONCLUDED AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    WHILE DRILLING OVER A GUIDE WIRE WITH A 3.0MM HEADLESS COMPRESSION SCREW INTO THE SCAPHOID AND GRAFT, THE TIP OF THE DRILL BIT BROKE OFF. TWO SMALL FRAGMENTS (LESS THAN 2MM ON X-RAY) REMAINED IN THE BONE AND COULD NOT BE RETRIEVED. THE DEVICE WAS LOST/MISPLACED AND NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI DRILL BIT HTW SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR GUIDE WIRE| SCREW