BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5 MM CANNULATED SCREW FULLY THREADED/50MM

    MDR report key: 1063382 · Received June 19, 2008

    Report

    Report Number
    1719045-2008-00079
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    November 7, 2007
    Report Date
    May 21, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K963172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. PART#: COMPLAINT ORIGINALLY FILED UNDER MFG RPT # 1719045-2007-00093, PART # 214.550, LOT UNK. PART NUMBER HAS BEEN UPDATED. ON LOT NUMBER WAS PROVIDED, WITH OUT A LOT NUMBER, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. PROD WAS REC'D AS TINY FRAGMENTS OF METAL, BONE, AND SOFT TISSUE IN CLEAR SOLUTION. IF THE SELF DRILLING PORTION OF THE THREAD CATCHES ON SOMETHING THREAD PEELING CAN OCCUR. INITIAL COMPLAINT DOES NOT SPECIFY WHETHER OR NOT THE SCREW MADE CONTACT WITH ANYTHING.

    Description of Event or Problem · 1

    PT HAD A 4.5 MM CANNULATED SCREW IMPLANTED IN THE ANKLE. DURING A F/U X-RAY METAL SHARDS WERE DISCOVERED IN THE ANKLE. REVISION SURGERY WAS DONE TO REMOVE THE METAL FROM THE ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5 MM CANNULATED SCREW FULLY THREADED/50MM CANNULATED SCREWS FULL THREAD HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention 4.5 MM CANN SCREW 40 MM