BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNA LOCKING TROCHANTERIC NAIL SYSTEM

    MDR report key: 7449979 · Received April 23, 2018

    Report

    Report Number
    9617297-2018-00002
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    March 13, 2018
    Report Date
    April 23, 2018
    Manufacturer
    U&I CORPORATION
    Product Code
    HSB
    PMA / PMN Number
    K093707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULDN'T DETERMINE THE CAUSE OF BREAKAGE BECAUSE SPECIFIC PATIENT AND CLINICAL INFORMATION WERE NOT PROVIDED. NO QUALITY PROBLEM WAS FOUND FROM DEVICE HISTORY RECORDS OF LOT 16E192. REFERENCE REPORT (B)(4).

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). A PATIENT UNDERWENT SURGRY IMPLANTING DYNA LOCKING TROCHANTERIC NAIL ON (B)(6) 2016. THE PATIENT RECENTLY COMPLAINED OF PAIN. IT WAS CONFIRMED THAT A TROCHANTERIC NAIL, 130-120X200MM AND NECK SCREW ASSEMBLY,90MM WERE BROKEN. BROKEN IMPLANTS REMOVAL AND REVISION SURGERY WERE PERFORMED AT ANOTHER HOSPITAL ON (B)(6) 2018. BUT THE SURGEON DID NOT REMOVE SEVERAL PIECES OF THE BROKEN NECK SCREW ASSEMBLY AND THEY REMAIN IN THE PATIENT'S BONE. THE PATIENT WAS IMPLANTED WITH ANOTHER COMPANY PRODUCTS. IT WAS REPORTED THAT AFTER REVISION SURGERY, THE PATIENT LEFT THE HOSPITAL AS GOOD. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295518 DYNA LOCKING TROCHANTERIC NAIL SYSTEM INTRAMEDULLARY FIXATION ROD HSB U&I CORPORATION 16E192

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention