BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDER F/SPLITFIX-PL 2 TI

    MDR report key: 3192516 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03846
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    October 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    PMA / PMN Number
    K964328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 SLIDER PLATE HAS HOLES THAT DO NOT COMPLY WITH OUR SPECIFICATIONS. THIS IS EVIDENTLY A PRODUCTION ERROR. UNFORTUNATELY, THIS ERROR WAS NOT DISCOVERED IN THE CONCLUSIVE QUALITY CONTROL. A DELIVERY STOP HAS ALREADY BEEN PLACED ON LOT 2313002. FURTHER INVESTIGATION OF THE ITEM WITH LOT 2358594 SHOWED THAT THIS BENDING AND THE SLIT HOLES ARE WIDENED. NO MEASUREMENTS CAN BE MADE FROM THESE DEFORMATIONS. WE ALSO DID NOT RECEIVE ANY OTHER COMPLAINTS ABOUT THIS BATCH AND DID NOT HAVE THE OPPORTUNITY TO TAKE MEASUREMENTS OF THE STOCK BECAUSE THE WHOLE BATCH WAS SOLD. WE CAN ONLY PRESUME THAT THE OCCURRENCE OF OVERSTRESSING THE IMPLANTS LEAD TO THIS FAILURE. ALSO, AN INTERNAL CORRECTIVE ACTION DETERMINATION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATES HAVE DIFFERENT SIZED HOLES AND THE SCREWS SLIP THROUGH. THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293574 SLIDER F/SPLITFIX-PL 2 TI JEY SYNTHES GMBH 2358594

    Patients

    Seq Age Sex Outcome Treatment
    1