BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL NAIL, A/R, R1500 9X360 MM

    MDR report key: 1850021 · Received September 27, 2010

    Report

    Report Number
    9610622-2010-00404
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 13, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K081152
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING T2 FEMORAL NAIL SURGERY, THE FEMORAL CANAL WAS REAMED 11MM THEN WHILE 9MM NAIL WAS INSERTED FROM THE APEX OF THE GREATER TROCHANTER, THE TIP OF THE NAIL WAS IMPINGED AT THE MEDIAL SIDE OF THE CANAL. THEN THE SURGEON HIT THE NAIL WITH THE HAMMER AND THE TIP OF THE NAIL LOOKED DEFORMED SO THE SURGEON REMOVED THE NAIL AND FOUND THAT THE NAIL WAS DEFORMED AT THE DISTAL SCREW HOLE. THE SURGEON USED 10MM NAIL WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL NAIL, A/R, R1500 9X360 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other