BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR Ø1.5 SELF-DRILL L5 TAN

    MDR report key: 3190032 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-02319
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    December 7, 2010
    Report Date
    May 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    PMA / PMN Number
    K042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 SCREWS WERE INSTALLED WITHOUT DRILLING. DURING FINAL TIGHTENING OF THE DEVICE SCREWS, NOT CONSISTENT WITH THE DEVICE LABELING INSTRUCTIONS, THE SCREW HEADS BROKE. AN EXAMINATION OF THE DHR RECORDS SHOW NO DEVIATIONS.

    Description of Event or Problem · 1

    SCREWS WERE BROKEN DURING FINAL TIGHTENING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290959 MATNEU SCR Ø1.5 SELF-DRILL L5 TAN JEY SYNTHES GMBH 2658374

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR