BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG

    MDR report key: 3001768 · Received March 11, 2013

    Report

    Report Number
    1719045-2013-10318
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    November 24, 2010
    Report Date
    December 14, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SIX PIECES WERE RECEIVED FOR MANUFACTURING INVESTIGATION, UNPACKAGED WITH NO LABELING. FOUR WERE IN THE CLIP WITH A LID AND TWO WERE IN THE CLIP WITH NO LID. VISUAL SPECIFICATION INVESTIGATION SHOWED THAT THE CLIP WAS LABELED "6" AND THE LENGTH OF THE SCREW WAS 12MM. HOWEVER, BECAUSE THE PRODUCT HAD BEEN REMOVED FROM ITS ORIGINAL PACKAGING PRIOR TO RETURNING IT, IT WAS DIFFICULT TO DETERMINE WHETHER THE PRODUCT WAS ACTUALLY RECEIVED IN THIS CONDITION, OR REMOVED FROM THE CLIP AND RETURNED TO A DIFFERENT CLIP. THEREFORE, THE COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 12MM SCREWS WERE PACKED INTO 6MM CLIPS. THESE WERE NOT USED DURING SURGERY. NO PT HARM. THIS IS REPORT 3 OF 6 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102454 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG JEY SYNTHES MONUMENT 6470976

    Patients

    Seq Age Sex Outcome Treatment
    1