BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNEC L141 F/INSERTION HANDLE

    MDR report key: 3183573 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03772
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    August 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE EVALUATION REVEALED THAT THE THREAD OF THE CONNECTOR, THE FIRST TWO TURNS RIPPED OFF, AS WELL AS THE THREAD OF THE SHOE IS BADLY DAMAGED. THERE ARE ALSO VISIBLE MARKS ON THE HEX SHAFT, INDICATING THAT BOTH PARTS MUST HAVE BEEN JAMMED UP OR TIGHTENED UP TO SUCH AN EXTENT THAT THE THREADS GO SO BADLY DAMAGED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THE PRODUCT WAS IN FULL COMPLIANCE WITH ITS SPECIFICATIONS AND THAT IT CORRESPONDS TO THE ACTUAL DESIGN. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW THREAD OF THE DRIVING CAP WITH HANDLE IS BROKEN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284401 CONNEC L141 F/INSERTION HANDLE LXH SYNTHES GMBH 3813682

    Patients

    Seq Age Sex Outcome Treatment
    1