BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, RIGHT 11X340MM X 125

    MDR report key: 2190425 · Received July 28, 2011

    Report

    Report Number
    9610622-2011-00332
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, SURGEON REMOVED THE ABOVE IMPLANTS. PT HAS NON UNION INTERTROCH FRACTURE WITH SUBTROCH INVOLVEMENT. COMPONENTS WERE REMOVED, FIRST SET SCREW THEN LAG SCREW THEN PROXIMAL PART OF BROKEN NAIL THEN DISTAL BROKEN NAIL. SURGEON CITED HIS SUSPICIONS FOR THE NON UNION AND BROKEN NAIL WERE, THE PT'S USE OF FOSAMAX AND A SOMEWHAT VARUS NAIL IN A RELATIVELY VALGUS NATURAL ANATOMIC PREFRACTURE FEMORAL NECK ANGLE. NAIL AND SCREWS WILL BE RETURNED. PREVIOUS TO THIS SURGERY, THE PT BROKE DISTAL LOCK SCREW AND TREATMENT AT A DIFFERENT HOSP WAS ANOTHER BRAND SCREW THROUGH THE DYNAMIC DISTAL NAIL HOLE. THAT SCREW WAS ALSO REMOVED AND IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R2.0, TI, RIGHT 11X340MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K176179

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention