BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3701375 · Received March 26, 2014

    Report

    Report Number
    2520274-2014-10474
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    July 28, 2013
    Report Date
    March 18, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN LOCKING SCREW, 3.9 MM, UNKNOWN PART/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. CONTACT OFFICE: SALEM, KHALED (2013, JUL 28): UNREAMED INTRAMEDULLARY NAILING IN DISTAL TIBIAL FRACTURES; INTERNATIONAL ORTHOPAEDICS (SICOT) (2013)37:2009-2015. 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 : "UNREAMED INTRAMEDULLARY NAILING IN DISTAL TIBIAL FRACTURES; KHALED HAMED SALEM; INTERNATIONAL ORTHOPAEDICS (SICOT) (2013)37:2009-2015. THE STUDY INCLUDED 101 DISPLACED UNSTABLE FRACTURES OF THE DISTAL TIBIAL THIRD TREATED USING UNREAMED NAILING. THERE WERE 66 MEN AND 35 WOMEN WITH A MEAN AGE OF 39.9 YEARS. UNION OCCURRED AFTER A MEAN TIME OF 23.9 WEEKS. THERE WERE 13 CASES OF DELAYED UNION AND SEVEN NON-UNIONS; ALL HEALED EVENTUALLY WITH ADDITIONAL SURGERY IN ONLY SIX FRACTURES. OF THE SEVEN NON-UNION CASES, 6 WERE MALE PATIENTS. MALUNION WAS SEEN IN 12 CASES, TEN OF WHICH WERE ASSOCIATED WITH UNPLATED FIBULAR FRACTURES. THREE FRACTURES (TWO OPEN) WERE TREATED FOR DEEP INFECTION, TWO OF THESE PATIENTS HAD SEPTIC NAIL LOOSENING AND BACKED-OUT DISTAL LOCKING SCREWS. THE MOST COMMON COMPLICATION SEEN WAS FATIGUE FAILURE OF THE LOCKING SCREWS. POSTOPERATIVE BREAKAGE WAS ALSO REPORTED WITH THE LOCKING SCREWS. BROKEN LOCKING SCREWS WERE REMOVED AT THE TIME OF NAIL REMOVAL. A BROKEN NAIL WAS REPORTED DUE TO EXTREME NON-COMPLIANCE IN AN ALCOHOLIC MALE PATIENT FOUR MONTHS AFTER INSERTION. THIS IS REPORT 4 OF 5 FOR (B)(4). THIS REPORT IS FOR UNKNOWN LOCKING SCREW, 3.9 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178193 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention