BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02802

    MDR report key: 3123133 · Received May 21, 2013

    Report

    Report Number
    2520274-2013-02802
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    February 22, 2011
    Report Date
    March 3, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. 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. PLACEHOLDER.

    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.(B)(4)

    Description of Event or Problem · 1

    BLOCKED HOLLOW DRILL WITH LEADING K WIRE, DURING DRILLING THE DRILL STOPPED AND WOULD NOT PERFORM FURTHER DRILLING. PROCEDURE WAS PERFORMED WITH A HOLLOW REAMER FROM ANOTHER SET. THIS IS 2 OF 2 REPORTS FOR THIS EVENT, COMPLAINT (B)(4). THIS REPORT IS FOR THE K-WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224923 HTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR