BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 14MM

    MDR report key: 3072423 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10739
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    July 2, 2012
    Report Date
    July 2, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    K981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. 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.

    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 PLATING PROCEDURE ON L MIDDLE CARPAL, THE SURGEON WAS USING AN EXTENDED H-PLATE WITH SEVEN SCREW HOLES. TWO OF THE SCREWS BROKE OFF IN THE PLATE DURING INSERTION. THE SURGEON UTILIZED OTHER HOLES TO COMPLETE THE PROCEDURE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173760 1.5MM TI CORTEX SCREW SELF-TAPPING 14MM MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR