BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02055

    MDR report key: 3070026 · Received April 22, 2013

    Report

    Report Number
    2520274-2013-02055
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(4) AS FOLLOWS: PATIENT WAS IMPLANTED WITH LCP MEDIAL DISTAL TIBIAL PLATE AND SCREW CONSTRUCT ON AN UNSPECIFIED DATE. PATIENT WAS RETURNED TO THE OR ON AN UNSPECIFIED DATE FOR A PLANNED REMOVAL OF THE HARDWARE. DURING THE REMOVAL, IT WAS REPORTED TWO SCREW HEADS BROKE OFF DESPITE USING A TORQUE LIMITER IN ACCORDANCE TO THE SPECIFICATIONS. REPORTEDLY THE PLATE AND SCREWS WERE NOT REMOVED AND THE TWO SCREWS WERE DISCARDED OF. NO CONSEQUENCE TO THE PATIENT WAS REPORTED. IT IS UNKNOWN WHICH SCREWS ARE BROKEN. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172457 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1