BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIKED WASHER 13.5MM/6.5MM

    MDR report key: 3003724 · Received March 14, 2013

    Report

    Report Number
    8030965-2013-10480
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    May 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTN
    PMA / PMN Number
    K011583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT AN INCORRECT LABEL WAS USED FOR THE COMPLETE LOT. A SCAN OF THE LABEL WAS RECEIVED FOR EVALUATION AND THE INCORRECT LABELING WAS CONFIRMED. THE LABEL WAS GIVEN FROM A US DOCUMENT AT THE TIME AND WAS THEREFORE USED FOR THIS ARTICLE. A NONCONFORMANCE REPORT WAS INTRODUCED IN 2009 FOR THIS ISSUE; THE US DOCUMENT WAS ADAPTED AND IS CORRECT TODAY.

    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 DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND THE LABELING WAS INCORRECT AS PER THE COMPLAINT DESCRIPTION. A CORRECTIVE AND PREVENTATIVE ACTION WAS INITIATED. THIS COMPLAINT IS VALID FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    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)(6) 2012. CLARIFICATION: THE DEVICE WAS NOT RETURNED; HOWEVER, THE PACKAGING WAS RETURNED AND EVALUATED (RESULTS PREVIOUSLY REPORTED).

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABELING IS INCORRECT. THE LABEL SHOULD READ 13.5,6.5 FOR LARGE SCREWS, BUT ACTUALLY READS 13.5,5.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107317 SPIKED WASHER 13.5MM/6.5MM HTN SYNTHES GMBH 2442736

    Patients

    Seq Age Sex Outcome Treatment
    1