BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-01755

    MDR report key: 3072406 · Received April 23, 2013

    Report

    Report Number
    2520274-2013-01755
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND REVIEWED. DUE TO THE CONDITION OF THE DEVICE THE MANUFACTURING EVALUATION WAS INDETERMINATE. THE MANUFACTURING EVALUATION STATES THE FOLLOWING: THE OVERALL LENGTH COULD NOT BE MEASURED SINCE SCREW IS IN TWO PIECES. THE FLUTES, THREAD PROFILE, THREAD MAJOR DIAMETER, AND THREAD MINOR DIAMETER COULD NOT BE INSPECTED DUE TO THREAD DAMAGE. SINCE ALL RELEVANT FEATURES COULD NOT BE CHECK DUE TO DAMAGE AND NO ISSUES WERE FOUND ON FEATURES THAT COULD BE INSPECTED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2013 DURING IMPLANTATION OF A CANNULATED SCREW CONSTRUCT FOR AN ORIF LEFT NAVICULAR THE SURGEON HEARD A POP AND NOTICED THE SCREW BROKE AT THE THREAD BODY. REPORTEDLY, ALL OF THE PIECES WERE RETRIEVED. THERE WAS A DELAY IN THE PROCEDURE AND A REPLACEMENT 4.0 X 34MM SCREW WAS INSERTED AND THE PROCEDURE WAS COMPLETED. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174695 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR