BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2902460 · Received January 8, 2013

    Report

    Report Number
    2520274-2013-00183
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 11, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4): 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.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HUMERAL NAIL-EX CONSTRUCT ON (B)(6) 2012. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE DUE TO NON-UNION. DURING THE REMOVAL PROCEDURE, ONCE THE PATIENT WAS OPENED UP, IT WAS NOTED THE PATIENT HAD AN INFECTION. ALL HARDWARE WAS REMOVED WITHOUT A PROBLEM. THE SURGEON DEBRIDED AND CLEANED UP THE CANAL. HE WAS ORIGINALLY GOING TO REPLACE THE IMPLANT BUT DECIDED TO GIVE THE PATIENT 2-6 WEEKS FOR HEALING. THE SURGEON WANTS TO WAIT AND SEE WHAT PATHOLOGY SAYS BEFORE RE-PLATING THE PATIENT. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9366 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention NAIL, SCREW