BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°

    MDR report key: 4123972 · Received September 27, 2014

    Report

    Report Number
    0009610622-2014-00509
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    May 13, 2007
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED VIA X-RAY. BOTH IMPLANTS WERE CLASSIFIED AS PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE IMPLANTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THE IMPLANTS WERE NOT AVAILABLE; THEREFORE AN INVESTIGATION OF THEM WAS NOT POSSIBLE. AS VISIBLE ON THE DELIVERED X-RAY THE RIGHT FEMUR FRACTURED BELOW THE IMPLANTED GAMMA3 NAIL IN A SPIRAL FRACTURE; THE IMPLANTS ARE NOT DAMAGED OR BROKEN. IT IS REPORTED THAT THE ADDITIONAL FRACTURE WAS CAUSED BY PATIENT¿S CONDITIONS (PATIENT FELL AT HOME), FURTHERMORE THE PATIENT IS DIABETIC, SCHIZOPHRENIC AND IS IN NEED OF CARE. THE IFU INCLUDES ¿ANY MENTAL DISORDER WHICH WOULD CREATE AN UNACCEPTABLE RISK OF FIXATION FAILURE OR COMPLICATIONS IN POSTOPERATIVE CARE¿ AS CONTRAINDICATION; FURTHERMORE, ANY ADDITIONAL TRAUMA AND DIABETES ARE ADVERSE EFFECTS AND CAN LEAD TO IMPLANT FAILURES. THE CASE IS ATTRIBUTED TO THE PATIENT; A DEVICE RELATED ISSUE CAN BE EXCLUDED. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    ACCIDENTAL FRACTURE UNDER THE NAIL. CHANGE INTO LONG NAIL (GAMMA3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603730 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K635174

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention