BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM

    MDR report key: 2897007 · Received January 4, 2013

    Report

    Report Number
    8030965-2013-00014
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 7, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K113364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. STERILIZATION VALIDATION DOCUMENTATION, DECISION FINDING PROTOCOLS, DFPS, WAS REVIEWED AND DEMONSTRATED THAT EACH OF THE PART NUMBERS INCLUDED WITHIN THIS COMPLAINT HAD BEEN EVALUATED FOR STERILIZATION. THE STERILIZATION PARAMETERS ARE CONSISTENT WITH SYNTHES CURRENT IFUS, AND THE SUPPORTING VALIDATIONS DEMONSTRATE THAT A STERILITY ASSURANCE LEVEL, SAL, OF 10, 6 IS ACHIEVABLE WHEN THE IFUS ARE EMPLOYED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH DISTAL FIBULA PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, PATIENT DEVELOPED AN OPEN LESION OVER THE PROXIMAL PART OF THE PLATE. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND ALL HARDWARE WAS REMOVED. THE SURGEON PLACED WOUNDVAC ON THE OPEN LESION, NO NEW HARDWARE WAS IMPLANTED, AND IT IS REPORTED THAT THE PATIENT IS RECOVERING WELL. SOFT TISSUE CULTURES AND THE HARDWARE WERE SENT TO HOSPITAL PATHOLOGY TO TEST FOR POSSIBLE INFECTION. THIS IS 2 OF 11 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4858 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM SCREW HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention PLATE, SCREWS