BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SUPRACONDYLAR NAIL (SCN) SYSTEM

    MDR report key: 8084239 · Received November 19, 2018

    Report

    Report Number
    8084239
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    September 11, 2018
    Report Date
    November 7, 2018
    Manufacturer
    STRYKER CORP.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    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 1 - LEFT DISTAL FEMUR FRACTURE S/P RETROGRADE INTRAMEDULLARY NAILING USING STRYKER SCN LAST YEAR. PROMINENT SCREW REMOVAL 5 MONTHS LATER. PATIENT 2 - LEFT DISTAL FEMUR FRACTURE S/P MULTIPLE SURGERIES WITH RETROGRADE INTRAMEDULLARY NAILING OF NONUNION USING STRYKER SCN LAST YEAR. PROMINENT SCREW REMOVAL ONE MONTH LATER. PATIENT 3 - RIGHT DISTAL FEMUR FRACTURE S/P RETROGRADE INTRAMEDULLARY NAILING USING STRYKER SCN EARLIER THIS YEAR. PROMINENT SCREW REMOVAL 5 MONTHS LATER. PATIENT 4 - LEFT DISTAL FEMUR FRACTURE INTRAMEDULLARY NAILING USING STRYKER SCN EARLIER THIS YEAR. PROMINENT SCREW REMOVAL 4 MONTHS LATER. MANUFACTURER RESPONSE FOR SUPRACONDYLAR NAIL, STRYKER SUPRACONDYLAR NAIL (SCN) SYSTEM (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926621 STRYKER SUPRACONDYLAR NAIL (SCN) SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER CORP.

    Patients

    Seq Age Sex Outcome Treatment
    0 25550 DA Other