BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3813347 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11277
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 25, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FOR TREATMENT, NOT DIAGNOSIS. "IPSILATERAL FRACTURES OF THE FEMORAL NECK, SHAFT AND DISTAL END: LONG-TERM OUTCOME OF FIVE CASES.¿ THIS REPORT IS FOR UNKNOWN DHS SCREWS/UNKNOWN LOT. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE "IPSILATERAL FRACTURES OF THE FEMORAL NECK, SHAFT AND DISTAL END: LONG-TERM OUTCOME OF FIVE CASES.¿ BARTONICEK, J., DOUSA, P., KUSIKOVA, E., LUNACEK, L., AND PAVELKA, T. (2011). INTERNATIONAL ORTHOPAEDICS (SICOT), 35:1083-1088. AT A LEVEL I TRAUMA CENTER, 52 PATIENTS WITH FEMORAL SHAFT FRACTURES COMBINED WITH PROXIMAL FEMORAL FRACTURES WERE TREATED BETWEEN JUNE 1994 AND MARCH 2008. ALL PATIENTS WERE OLDER THAN 18 YEARS OF AGE. THERE WERE FOUR MALE AND ONE FEMALE PATIENT, RANGING IN AGE FROM 26 TO 51 YEARS. THE MECHANISM OF INJURY WAS ALWAYS HIGH-ENERGY TRAUMA INVOLVING A MOTOR VEHICLE ACCIDENT, RESULTING IN POLYTRAUMA. HOWEVER, IN TWO CASES, INITIAL TREATMENT WAS DIRECTED TOWARDS THE DISTAL FEMORAL FRACTURE, STABILIZING IT WITH THE HELP OF A 95° BLADE PLATE, WHICH, AT THE SAME TIME, DEALT WITH THE DIAPHYSEAL FRACTURE. IN THESE PATIENTS, THE PROXIMAL FRACTURE WAS TREATED USING DYNAMIC HIP SCREWS. A (B)(6) MAN WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AS A DRIVER. HE SUFFERED FRACTURES OF BOTH FEMURS. THE FRACTURE OF RIGHT NECK WAS TREATED USING A DYNAMIC HIP SCREW (DHS SYNTHES). THE FIXATION OF DIAPHYSIS AND DISTAL PART OF RIGHT FEMUR WAS PERFORMED USING A 95° BLADE PLATE. THE FRACTURE OF THE NECK OF THE RIGHT FEMUR HEALED IN THREE MONTHS AND THAT OF THE DISTAL FEMUR HEALED IN SIX MONTHS. A DELAYED UNION OCCURRED IN SHAFT FRACTURE, A DECORTICATION WITH CANCELLOUS BONE GRAFTING WAS THEREFORE PERFORMED SIX MONTHS AFTER THE INJURY. THIS IS REPORT 2 OF 2 FOR (B)(40. THIS REPORT IS FOR UNKNOWN DHS SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292012 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention