BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    MDR report key: 2972594 · Received February 21, 2013

    Report

    Report Number
    1719045-2013-10139
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 12, 2012
    Report Date
    January 12, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    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)

    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

    AS REPORTED, THE PATIENT WAS BEING TREATED FOR LEFORTE II AND III FRACTURES. AS THE SURGEON WAS TIGHTENING A MATRIXMIDFACE SCREW, SELF-DRILLING, THE HEAD OF THE SCREW BROKE INTO MANY SMALL PIECES. THE SURGEON LEFT THE SHAFT IN THE PATIENT AND COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. ANY POSSIBLE DEBRIS WAS FLUSHED AND SUCTIONED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75427 TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR