BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/INSERTION DHS BLADE

    MDR report key: 3151252 · Received June 7, 2013

    Report

    Report Number
    8030965-2013-02826
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    July 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION HAS SHOWN SHOWS THAT THE THREADED TIPS ARE COMPLETELY BROKEN OFF. IT IS UNKNOWN WHERE THE BROKEN OFF THREADED PORTIONS ARE. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF FAILURE. WE DO PRESUME THOUGH, THAT THE BREAKAGE OCCURRED DURING A MECHANICAL OVERLOADING SITUATION. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WHILE WE DO PRESUME THAT THE BREAKAGE OCCURRED DURING A MECHANICAL OVERLOADING SITUATION, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTOR OF THE LCP DHS, LOCKING COMPRESSION PLATE DYNAMIC HIP SYSTEM BLADE WAS BROKEN IN SPIRAL TAIL FOR AN UNCLEAR REASON DURING THE SURGERY. BECAUSE OF THIS THE SURGERY COULD NOT BE PERFORMED SMOOTHLY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252757 CONNECSCR F/INSERTION DHS BLADE LXH SYNTHES GMBH 2260851

    Patients

    Seq Age Sex Outcome Treatment
    1