BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVERS

    MDR report key: 3960947 · Received July 28, 2014

    Report

    Report Number
    2520274-2014-12823
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWDRIVER/UNKNOWN LOT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PLATE AND SCREWS HAD IMPLANTED ON (B)(6) 2012. THE REMOVAL OPERATION WAS PERFORMED ON (B)(6) 2014. THE SCREWS WHICH HAD BEEN IMPLANTED IN THE PROXIMAL SCREW HOLES WERE REMOVED WITH THE SCREWDRIVER WITHOUT ANY PROBLEM. THEN THE SURGEON TRIED TO REMOVE THE SCREWS IN THE DISTAL SCREW HOLES WITH THE SCREWDRIVER ALSO, BUT THE RECESS OF THE SCREWS WERE DAMAGED, SO THE SURGEON USED THE EXTRACTION SCREWS, BUT STILL WASN¿T ABLE TO REMOVE THEM. THE SURGEON DECIDED TO LEAVE THE PLATE AND SCREWS IN THE PATIENT AND COMPLETED THE OPERATION WITH A DELAY OF TEN MINUTES. THIS REPORT IS FOR AN UNKNOWN SCREWDRIVER. THIS IS REPORT 3 OF 4 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439461 SCREWDRIVERS HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1