BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUPRACONDYLAR NAIL LOCKING SCREW

    MDR report key: 8182767 · Received December 19, 2018

    Report

    Report Number
    0009610622-2018-01521
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    September 1, 2018
    Report Date
    December 19, 2018
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS PI IS FOR PATIENT 4 OF 4. AS REPORTED IN MEDWATCH # (B)(4): "WE HAVE EXPERIENCED FOUR CASES WHERE THE DISTAL LOCKING SCREW OF THE STRYKER SUPRACONDYLAR NAIL (SCN) SYSTEM DISENGAGES FROM THE BONE AND NAIL. IN ALL FOUR CASES THE SCREWS HAVE BACKED OUT TO THE POINT THAT THEY WERE PROMINENT AND PAINFUL THEREBY NECESSITATING SURGICAL REMOVAL...PATIENT 4: LEFT DISTAL FEMUR FRACTURE INTRAMEDULLARY NAILING USING STRYKER SCN EARLIER THIS YEAR. PROMINENT SCREW REMOVAL 4 MONTHS LATER". REVISION, PAIN, LOOSENED LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017539 UNKNOWN SUPRACONDYLAR NAIL LOCKING SCREW IMPLANT HWC STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention