BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-04032

    MDR report key: 3203630 · Received July 3, 2013

    Report

    Report Number
    2520274-2013-04032
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR TWO UNKNOWN CANNULATED SCREWS. IMPLANT AND EXPLANT DATES ARE UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THIS REPORT IS AN INVESTIGATOR INITIATED STUDY - DIRECTED GRANT REQUEST PROVIDED BY SYNTHES UNDER GRANT NUMBER (B)(4). STUDY PROJECT TITLED: FATIGUE CHARACTERISTICS OF FULLY THREADED AND PARTIALLY THREADED CANNULATED SCREWS FOR BIOMECHANICAL RESEARCH. THE PROPOSED STUDY AIMS TO TREAT ADOLESCENT SUBJECTS DIAGNOSED WITH SLIPPED CAPITAL FEMORAL EPIPHYSIS (SCFE). DOCUMENTED WITHIN THE LETTER OF INTENT FOR THE GRANT, THE INTRODUCTION NOTED THAT THERE WERE TWO PREVIOUSLY REPORTED CASES OF CANNULATED SCREW FAILURE FOLLOWING IN-SITU SCFE FIXATION, BOTH OCCURRING CLOSE TO THE MID-POINT OF THE CANNULATED SCREW WITHIN THE FEMORAL NECK (FAILURES, PART NUMBERS, LOT NUMBERS, SUBJECTS, TIME OF EVENT AND OUTCOME UNSPECIFIED). THIS REPORT IS FOR THE TWO UNKNOWN CANNULATED SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305675 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1