BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANCELLOUS BONE SCREW FULLY THREADED/55MM

    MDR report key: 3071393 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10839
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 25, 2012
    Report Date
    July 25, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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

    IT WAS REPORTED THAT DURING A RIGHT ELBOW OPEN REDUCTION INTERNAL FIXATION PROCEDURE, THE SCREW BROKE DURING THE INSERTION. THE HEAD OF THE SMALL PORTION OF THE SCREW BROKE OFF AND STILL REMAINS IN THE PATIENT. THE SURGEON CHOSE TO LEAVE IT AS IS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT AND NO ADVERSE EVENT WAS NOTED. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171422 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/55MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR