BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125

    MDR report key: 2910476 · Received January 8, 2013

    Report

    Report Number
    9610622-2013-90016
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: (B)(4) K-WIRE GAMMA 3, 2X450 MM LOT#K886122; (B)(4) 4.2X300 MM DRILL LOT# K390262; 1806-0085S GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR 3X1000 MM LOT#K115335; (B)(4) LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40MM LOT# K138952; (B)(4) LAG SCREW, TI GAMMA3 10.5X95MM LOT# K716339.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR HAD A GAMMA NAIL REMOVAL ON (B)(6) 2012 AT (B)(6). THE REASON FOR IMPLANT REMOVAL WAS NOT DISCLOSED. PER PHYSICIAN REQUEST THERE WERE NO STRYKER SALES REPRESENTATIVES PRESENT FOR IMPLANT REMOVAL. A STRYKER SALES REPRESENTATIVE ENSURED ALL PROPER INSTRUMENTATION WAS PRESENT FOR IMPLANT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8722 TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K251416

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other| R