BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK SCR Ø2 SELF-TAP L5 TAN 1U I/CLIP

    MDR report key: 3181104 · Received June 20, 2013

    Report

    Report Number
    2520274-2013-03616
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 9, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE ADDITIONAL EVALUATION REVEALED THAT THE MEASURABLE DIMENSIONS OF THE SUBMITTED MATRIXMANDIBLE SCREWS WERE TESTED. IT WAS DETERMINED THAT THESE MEET THE DRAWINGS AND THE AO/ASIF SPECIFICATIONS. SINCE THE EXACT LOT NUMBERS OF THESE MATRIXMANDIBLE ARE NOT KNOWN, THE EXACT TIME OF MANUFACTURING AND THE PRODUCT DOCUMENTATION CANNOT BE VERIFIED. THUS IT CAN MERELY BE STATED THAT OUR MATRIXMANDIBLE SCREWS MEET THE AO/ASIF SPEFICIATIONS MEET THE INTERNATIONAL STANDARDS. BASED ON THE AVAILABLE MATRIXMANDIBLE SCREWS, WE CAN ONLY SUSPECT THAT THE DAMAGE WAS CAUSED BY EXCESSIVE MECHANICAL LOAD WHICH STRIPPED THE THREAD. THERE IS NO MATERIAL ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH SCREWS LOST THEIR THREADING WHEN REMOVING THE METAL, OR THE THREAD WAS REMOVED FROM THE SCREWS. IT CAN NO LONGER BE DETERMINED WHAT THE LENGTH OF THE SCREWS WAS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280034 LOCK SCR Ø2 SELF-TAP L5 TAN 1U I/CLIP JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1