BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 125°

    MDR report key: 4120494 · Received September 26, 2014

    Report

    Report Number
    0009610622-2014-00504
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 3, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NAIL WAS CLASSIFIED AS PRIMARY PRODUCT. TECHNICAL EVALUATION: NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE NAIL RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. BECAUSE IT WAS NOT RETURNED AN INSPECTION OF IT WAS NOT POSSIBLE. CLINICAL EVALUATION: THE AVAILABLE INFORMATION AND X-RAYS WERE PRESENTED TO A MEDICAL EXPERT: "X-RAYS SHOW THAT PATIENT HAD A POOR BONE QUALITY (MOST LIKELY OSTEOPOROSIS). THE LAG SCREW CUT OUT COULD BE CONFIRMED ON THE X-RAY FROM (B)(6) 2014, AP-VIEW. BECAUSE AN X-RAY SHORTLY AFTER THE INITIAL SURGERY COULD NOT BE IDENTIFIED THE ORIGINAL LAG SCREW POSITION COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE LAG SCREW CHOSEN WAS TOO LONG. THE EXACT ROOT CAUSE OF THE CUT OUT COULD NOT BE DETERMINED BASED ON THE GIVEN INFORMATION AND X-RAYS." THE CORRECT IMPLANT LENGTH AND COMBINATION IS ADDRESSED IN THE IFU; FURTHERMORE POOR BONE QUALITY CAN LEAD TO IMPLANT FAILURES. MOST LIKELY THE LAG SCREW CUT THROUGH THE BONE DUE TO A MOVEMENT OF THE FEMUR HEAD COMPONENT CAUSED BY POOR BONE QUALITY IN COMBINATION WITH POSTOPERATIVELY LOADS. NO NON-CONFORMITY IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    X-RAY SHOWS CUT OUT OF THE SCREW. FOR THIS REASON, THE PATIENT COMPLAINED OF PAIN AND FUNCTIONAL LIMITATION. REVISION SURGERY (B)(6).

    Description of Event or Problem · 1

    X-RAY SHOWS CUT OUT OF THE SCREW. FOR THIS REASON, THE PATIENT COMPLAINED OF PAIN AND FUNCTIONAL LIMITATION. REVISION SURGERY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601290 TROCHANTERIC NAIL KIT, STST GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K069107

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR