BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6878728 · Received September 20, 2017

    Report

    Report Number
    2520274-2017-12296
    Event Type
    Injury
    Date Received
    September 20, 2017
    Report Date
    September 7, 2017
    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

    KUHN, K; ET AL; INCREASED NONUNION RATE AND DELAYED UNION OF DISTAL TIBIA FRACTURES TREATED WITH INTRAMEDULLARY NAILS AND ANGLE STABLE INTERLOCKING SCREWS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. (B)(4). 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE POSTER: KUHN, K; ET AL; INCREASED NONUNION RATE AND DELAYED UNION OF DISTAL TIBIA FRACTURES TREATED WITH INTRAMEDULLARY NAILS AND ANGLE STABLE INTERLOCKING SCREWS. THIS IS A RETROSPECTIVE POSTER REVIEW OF 22 CONSECUTIVE PATIENTS WITH DISTAL TIBIA FRACTURES, WITH OR WITHOUT SIMPLE INTRA-ARTICULAR EXTENSION, TREATED WITH INTRAMEDULLARY NAILING WITH ANY NUMBER OF ANGLE STABLE INTERLOCKING SCREWS (ASIS) PLACED IN THE DISTAL SEGMENT. OF THE 16 PATIENTS WHO MET INCLUSION CRITERIA, THERE WERE 6 OPEN FRACTURES. NINE FRACTURES WERE CLASSIFIED AS OTA TYPE A, THREE AS OTA TYPE B, AND FOUR OTA TYPE C FRACTURES. THE AVERAGE TIME UNTIL UNION WAS 30 WEEKS. THERE WERE NO DEEP INFECTIONS OR ASIS FAILURES IN THE STUDY GROUP. THERE WERE NO MALUNIONS. ONE FRACTURE WAS MALALIGNED AFTER THE INDEX PROCEDURE AND WENT ON TO A TRANSTIBIAL AMPUTATION FOR NONUNION. A COPY OF THE POSTER REVIEW WILL BE ATTACHED TO THE MEDWATCH. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ASIS AND REFERS TO THE SERIOUS INJURY OF 1 UNKNOWN PATIENT WHO EXPERIENCED FRACTURE MALALIGNED AND A TRANSTIBIAL AMPUTATION FOR NONUNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660106 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention