BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    MDR report key: 3902158 · Received June 30, 2014

    Report

    Report Number
    0009610622-2014-00295
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SCREW WAS PACKED UNDER CLEAN ROOM CONDITIONS. AFTER THE PACKAGING PROCESS THE IMPLANTS WERE EXPOSED TO GAMMA RADIATION FOR STERILIZATION. ACCORDING TO DQF 13-002 THE DOCUMENTED TEST RESULTS WERE REVIEWED FOR THIS INVESTIGATION AND NO DEVIATION WAS FOUND. INVESTIGATION SUGGESTS THAT THE SCREW WAS STERILE AT THE TIME OF DISTRIBUTION. GENERAL TECHNICAL ASPECT: IF THE STERILE BARRIER OF THE PACKAGE IS OPENED OR SUSPECTED BEING IMPAIRED (I.E. TRANSPORT ISSUE OR INSUFFICIENT USAGE IN HOSPITAL) THE IFU INSTRUCT THAT IN THESE CASES THE PRODUCT MUST BE RE-STERILIZED IN CASE OF USE. NONE OF THE SCREWS FROM THE SAME LOT IS REPORTED TO HAVE CAUSED ANY INFECTION PROBLEMS. BASED ON THE REVIEW OF ALL RELEVANT DOCUMENTS FROM THE MANUFACTURER SITE AND ON THE INFORMATION PROVIDED BY THE CUSTOMER NO EVIDENCE FOR A DEVICE RELATED REASON OF THE REFERRED COMPLICATIONS HAS BEEN FOUND. IN A SIMILAR CASE, A MEDICAL EXPERT STATED: ¿WHEN USING AN INTRAMEDULLARY NAIL, THE RISK OF AN INFECTION IS WELL KNOWN, ESPECIALLY IN THE DISTAL THIRD OF THE TIBIA SHAFT. THE INCREASED INFECTION RATE AND NON-UNION RATE IN THIS AREA OF THE TIBIA IS CAUSED BY ANATOMICAL ASPECTS AND INJURY RELATED DAMAGE OF THE LOCAL BLOOD SUPPLY AND AN INJURY RELATED ALTERATION OF THE SOFT TISSUE COVERING THE TIBIA AT THE FRACTURE SITE.¿ NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS AN INFECTED LEFT TIBIA FROM A PREVIOUS INDEX TRAUMA SURGERY, SO THE HARDWARE WAS REMOVED. A I & D WAS PERFORMED AND NEW TRAUMA DEVICES WERE IMPLANTED. NO ADDITIONAL INFORMATION WILL BE PROVIDED TO THE SALES REP FROM THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS AN INFECTED LEFT TIBIA FROM A PREVIOUS INDEX TRAUMA SURGERY SO THE HARDWARE WAS REMOVED. A I & D WAS PERFORMED AND NEW TRAUMA DEVICES WERE IMPLANTED. NO ADDITIONAL INFORMATION WILL BE PROVIDED TO THE SALES REP FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379802 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K0D00D0

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention