BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI TRANSCONNECTOR 60MM

    MDR report key: 2972419 · Received February 15, 2013

    Report

    Report Number
    2530088-2013-10036
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2010
    Report Date
    January 26, 2011
    Manufacturer
    SYNTHES 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

    SYTHES 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 ADD¿L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE ORIGINAL LOT NUMBER WAS 6153429. THE LOT NUMBER CHANGED ONCE THE DEVICE WAS REPACKAGED AT (B)(4). DEVICE RECEIVED IN (B)(4) 2010. DEVICE NOT AVAILABLE FOR EVAL. A REVIEW OF THE MFG RECORD HAS BEEN REQUESTED. CONCLUSION NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    (B)(6) CENTER OF SYNTHES (B)(6) 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 1 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69448 TI TRANSCONNECTOR 60MM KWP SYNTHES BRANDYWINE 3216941

    Patients

    Seq Age Sex Outcome Treatment
    1