BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL UNILOCK-SCR 3 SELF-TAP L16 5U

    MDR report key: 3083414 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10965
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    May 3, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K093772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. PRODUCT WAS RECEIVED IN A SEALED, UNOPENED PACKAGE FOR A MANUFACTURING EVALUATION. THE LABEL ON THE PACKAGE HAD AN INVALID LOT NUMBER. THIS COMPLAINT IS VALID FROM A MANUFACTURING STANDPOINT. A CAPA RISK ASSESSMENT WAS COMPLETED FOR THE IDENTIFIED NON-CONFORMANCE. BASED ON THE RESULTS OF THIS RISK ASSESSMENT A CAPA WILL NOT BE INITIATED.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOT NUMBER ON THE LABEL WAS NOT CORRECT. THE LOT NUMBER ON THE LABEL WAS 413.586, BUT SHOULD HAVE BEEN 6901759. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185625 STERNAL UNILOCK-SCR 3 SELF-TAP L16 5U HWC SYNTHES MONUMENT 6901759

    Patients

    Seq Age Sex Outcome Treatment
    1