BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø2 SELF-TAP L38 TAN

    MDR report key: 3183145 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03109
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    August 24, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQN
    PMA / PMN Number
    K981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 HEAD TEXT ON THE LABEL OF BOTH PACKAGES GIVES THE WRONG LENGTH (LOT #1255365 L6MM, LOT #8008267 L36MM). LOT 1255365 WAS MANUFACTURED IN MAY 2004 AND LOT 8008267 IN JULY 2012. THIS OBVIOUSLY RELATES TO A LABEL ERROR, WHICH WAS UNFORTUNATELY NOT DISCOVERED DURING THE FINAL QUALITY CONTROL. WE WOULD LIKE TO ENSURE YOU THAT WE HAVE RECORDED THIS ON OUR MARKET VIGILANCE SYSTEM AND THE REQUIRED CORRECTION MEASURES HAVE BEEN PROMPTED. THE TEXT ON THE LABEL DOES NOT CORRESPOND WITH THE GUIDELINES. AN INTERNAL CORRECTIVE ACTION DETERMINATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. HOWEVER A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    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 METHOD CODE WAS ADDED FOR DEVICE HISTORY RECORD REVIEW. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. (B)(6). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ONE SCREW (401.838/1255365) HAS THE WRONG LENGTH WRITTEN IN THE HEADING OF THE LABEL. LENGTH SHOULD BE L38MM NOT L5MM. ALSO ANOTHER SCREW (401.838/8008267) WAS MISSING THE SCREW ALL TOGETHER. THE HEADING OF THE LABEL ON THIS SCREW THE LENGTH IS MARKED WRONGLY AS L36MM, IN MULTILINGUAL TEXT IT IS HOWEVER CORRECT WITH L38MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284001 CORTSCR Ø2 SELF-TAP L38 TAN MQN SYNTHES GMBH 1255365

    Patients

    Seq Age Sex Outcome Treatment
    1