BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM

    MDR report key: 2827296 · Received November 9, 2012

    Report

    Report Number
    2520274-2012-02241
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    September 13, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. BASED ON THE MANUFACTURING EVALUATION, THE MANUFACTURING ENGINEER DETERMINED THE PART NUMBER OF THIS SCREW TO BE 212.105. THIS PART IS A 3.5MM LOCKING SCREW SELF TAPPING WITH STARDRIVE RECESS 18MM. VISUAL INSPECTION NOTED THE SCREW WAS RECEIVED INTACT AND WHOLE THE DRIVE HAS NO NOTICEABLE DAMAGE. THE HEAD THREADS ARE IN GOOD CONDITION. THE SHAFT THREADS ARE ALSO IN GOOD CONDITION, AS ARE THE FLUTES AND THE TIP. THE MAJOR DIAMETER IS 3.48MM. THIS SCREW APPEARS TO BE OF THE 212-101 FAMILY OF SCREWS. IF SO, THE LENGTH OF 18.64MM WOULD MAKE THIS A 212.105. DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO MEET SPECIFICATIONS. THE PLATE AND SCREWS FUNCTIONED PROPERLY AS DESIGNED IN THAT THEY PROVIDED SUFFICIENT FRACTURE FIXATION TO ALLOW BONY HEALING. IN THE INTENDED POSTERIOR POSITION, THE SHAPE OF THE PLATE IS SUCH THAT IT SHOULD NOT IMPINGE ON AN ULNAR NERVE IN THE ANATOMIC POSITION. THE ACTUAL POSITION OF THE NERVE POST-INJURY AND VARYING ANATOMY COULD POSSIBLY HAVE CONTRIBUTED TO THE NERVE BEING IN AN ABNORMAL LOCATION. IN ADDITION, THIS IS A STAINLESS STEEL PLATE. IT IS KNOWN THAT STAINLESS STEEL CAN ELICIT SENSITIVITY REACTIONS IN SOME PATIENTS. THE ULNAR NERVE COMPRESSION COULD HAVE RESULTED FROM ABNORMAL ANATOMY, A REACTION TO THE NICKEL IN THE PLATE, OR DAMAGE FROM THE ORIGINAL TRAUMATIC EVENT WITHOUT ANY EFFECT FROM THE IMPLANT. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    MED WATCH (B)(4) WAS RECEIVED AND A COPY WILL BE INCLUDED WITH THE REPORT. THIS IS 6 OF 12 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREW| PLATE