BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE Ø2 THREAD-TIP L280 SST

    MDR report key: 3183156 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03239
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 25, 2012
    Report Date
    June 7, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K961413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LSS-DF CASE THE K-WIRE WAS BROKEN DURING THE OPERATION. THE BROKEN PART WAS RETAINED IN THE PATIENTS SITE. THE PART WAS DISCARDED BY THE HOSPITAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282878 K-WIRE Ø2 THREAD-TIP L280 SST HWC SYNTHES GMBH 7520744

    Patients

    Seq Age Sex Outcome Treatment
    1