BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNA LOCKING TROCHANTERIC NAIL

    MDR report key: 6756187 · Received July 31, 2017

    Report

    Report Number
    9617297-2017-00001
    Event Type
    Injury
    Date Received
    July 31, 2017
    Date of Event
    March 13, 2017
    Report Date
    March 27, 2017
    Manufacturer
    U&I CORPORATION
    Product Code
    HSB
    PMA / PMN Number
    K093707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO QUALITY PROBLEM WAS FOUND FROM MANUFACTURING AND INSPECTION RECORDS OF LOT 15I209-1. THE BREAKAGE OCCURRED AT DIA.11.0MM THRU. HOLE ON TROCHANTERIC NAIL WHERE SUPPORTS NECK SCREW ASSEMBLY. IT WAS EVALUATED THAT THE NAIL WAS BROKEN BY IMPROPER REDUCTION OF THE FRACTURED BONES.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). THE PATIENT UNDERWENT SURGERY IMPLANTING DYNA LOCKING TROCHANTERIC NAIL AT HOSPITAL IN (B)(6). THE PATIENT WAS (B)(6) AND COMPLAINED OF PAIN A MONTH AND HALF AFTER SURGERY. IT WAS IDENTIFIED THAT A NAIL BROKE. THE BROKEN NAIL WAS REMOVED AND REPLACED WITH OTHER COMPANY'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536036 DYNA LOCKING TROCHANTERIC NAIL INTRAMEDULLARY FIXATION ROD HSB U&I CORPORATION 15I209-1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention