BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLD-SL W/LOCK F/PEDIC SCR CLICKX STANDA

    MDR report key: 3163052 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-02318
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    April 26, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT TWO PRONGS OF THE PRESENT HOLDING SLEEVE WERE BROKEN OFF. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT BROKE AND CAN NOT CATCH THE SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263568 HOLD-SL W/LOCK F/PEDIC SCR CLICKX STANDA MNI SYNTHES GMBH 1391993

    Patients

    Seq Age Sex Outcome Treatment
    1