BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-04051

    MDR report key: 3212386 · Received July 9, 2013

    Report

    Report Number
    2520274-2013-04051
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2013, DURING A TFN INSERTION, THE BLADE WOULD NOT ADVANCE FULLY. THE SURGEON TAPPED IN THE BLADE, FOLLOWING THE SURGICAL TECHNIQUE. THE CONNECTING SCREW 357.377 THAT JOINS THE BLADE TO THE IMPACTOR 357.372 SNAPPED. THIS MEANT THAT THE BLADE WAS STILL ATTACHED TO THE IMPACTOR WITH NO WAY OF UNSCREWING THE CONNECTING SCREW AND DISENGAGING THE BLADE. THIS RESULTED IN AN INCREASE TIME IN SURGERY TO EXTRACT THE BLADE AND REPLACE IT WITH ANOTHER. IT SHOULD BE NOTED THAT THE SURGICAL TECHNIQUE WAS FULLY ADHERED TO. THE CASE WENT ON FOR ANOTHER 35 MINUTES. ON (B)(6) 2013, THE BROKEN SCREW WAS RECEIVED AND THE LOT INDICATED ON DEVICE. ONLY THE BROKEN CONNECTING SCREW WILL BE COMING BACK. THIS REPORT IS FOR AN UNKNOWN PART. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312274 LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1