BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI TRANSCONNECTORS 60MM

    MDR report key: 2972417 · Received February 15, 2013

    Report

    Report Number
    2530088-2013-10038
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2010
    Report Date
    January 26, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K091689
    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. ADDITIONAL INFORMATION: THE ORIGINAL LOT NUMBER WAS 6235312. THE LOT NUMBER CHANGED ONCE THE DEVICE WAS REPACKAGED AT (B)(4). DEVICE RECEIVED IN (B)(4) 2010. DEVICE NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORD HAS BEEN REQUESTED. CONCLUSION NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    (B)(4) OF SYNTHES (B)(4) INFORMED SYNTHES PRODUCT SERVICE, (B)(4), THAT MULTIPLE UNOPENED TRANSVERSE AND TRANSCONNECTORS WERE FOUND ON INCOMING INSPECTION TO HAVE THE SCREWS COMPLETELY SEPARATED FROM THE DEVICES INSIDE THE PACKAGES. THIS IS 2 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69519 TI TRANSCONNECTORS 60MM KWP SYNTHES (USA) BRANDYWINE 3192928

    Patients

    Seq Age Sex Outcome Treatment
    1