BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIANCE,FIXATION,NAIL

    MDR report key: 4133338 · Received October 1, 2014

    Report

    Report Number
    2520274-2014-13872
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    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 AN UNKNOWN QUANTITY OF SCHANZ SCREWS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    IT WAS REPORTED THAT WHEN USING SELF-DRILLING SCHANZ SCREWS ALONG WITH A DRILL GUIDE, THE SCREWS CAN BECOME STUCK IN THE SLEEVE DUE TO BONE DEBRIS GOING UP THE DRILL GUIDE. THIS LEADS TO UNKNOWN TIME DELAYS DURING THE PROCEDURE. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF SCHANZ SCREWS. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610862 APPLIANCE,FIXATION,NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1