BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEND-SCR F/UNILOCK-RECOPL TI

    MDR report key: 3183644 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03911
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    April 2, 2012
    Report Date
    April 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICES WERE RETURNED FOR INSPECTION AND THE EVENT DESCRIPTION CONFIRMED. THE VISUAL INSPECTION WAS COMPLETED AND THE MEASURABLE DIMENSIONS OF THE ITEMS WERE IN COMPLIANCE WITH THE PRINT SPECIFICATIONS. IMAGES WERE TAKEN AND ATTEMPTS WERE MADE TO SIMULATE THE INCIDENT. THE MATERIALS WERE EXAMINED IN A METALLOGRAPHIC CROSS SECTION AND FOUND TO BE IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS. THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS AND NO PRODUCT FAULT COULD BE DETECTED. THE SURGEON MENTIONED THAT THE SET IS OLD AND NOT USED FREQUENTLY AND THE MANUFACTURING RECORDS REVEALED THAT THESE PRODUCTS ARE ALMOST 10 YEARS OLD. THE SUSPECT PRODUCT MAY HAVE BEEN USED MULTIPLE TIMES, RESULTING IN FATIGUE FRACTURE OF THE THREADS. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AS NO PRODUCT FAULT COULD BE DETECTED. AS THE FINDINGS CONCLUDE THAT THE SUSPECT PRODUCT MAY HAVE BEEN USED MULTIPLE TIMES, THE DEVICE FAILURE MAY BE DIRECTLY RELATED TO THE FACT THAT THESE DEVICES HAVE REACHED THE END OF THEIR USEFUL LIFE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED WITH A UNILOCK PLATING SYSTEM AND THREADS OF METAL CAME OFF WITH THE USE OF THE BENDING SCREWS. BEFORE BENDING THE PLATE THE SURGEON INSERTED BENDING SCREWS IN THE HOLES OF THE PLATE. WHEN REMOVING THE BENDING SCREWS FROM THE PLATE, SEVERAL THREADS OF METAL CAME OFF THE SCREWS. PHOTOGRAPHS WERE TAKEN. THE PLATE WAS CLEANED WITH STERILE WATER AND THEN IMPLANTED. THERE WERE NO PROBLEMS INSERTING THE LOCKING SCREWS IN THE PLATE. ALL THE BENDING SCREWS WERE RETURNED AS IT WAS NOT POSSIBLE TO SEE WHICH ONE WERE USED DURING THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 15 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284339 BEND-SCR F/UNILOCK-RECOPL TI LXH SYNTHES GMBH 1203113

    Patients

    Seq Age Sex Outcome Treatment
    1