BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 3051315 · Received April 10, 2013

    Report

    Report Number
    8030965-2013-10725
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    June 2, 2012
    Report Date
    June 2, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PRODUCT DEVELOPMENT EVALUATION REVEALS THAT THE SAMPLE WAS RECEIVED WITH THE TANG BROKEN OFF AS REPORTED. THERE IS A SMALL AMOUNT OF THE BASE OF THE TANG REMAINING AT THE END OF THE BARREL. A CRACK LOCATED ALONG THE BASE ON ONE SIDE, GOES ACROSS THE FULL WIDTH OF THE BARREL. THERE ARE NUMEROUS DINGS AND DENTS ON THE UNDERSIDE OF THE INSERTION HANDLE AND TWO LARGE METAL BURRS HAVE BEEN MOVED INTO THE 120° HOLE. THERE ARE SIGNIFICANT DENTS AND DEFORMATION ON THE FRONT EDGE OF THE REAR DRIVING CAP MOUNTING HOLE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE TANG IS INTENDED TO ALIGN AND HOLD THE POSITION OF THE INSERTION HANDLE WITH THE NAIL DURING INSERTION. THE HANDLE DOES ROTATE FROM AN ANTERIOR TO A LATERAL POSITION DURING INSERTION FOLLOWING THE CURVATURE OF THE NAIL AND FEMORAL CANAL BUT SHOULD BE SUBJECTED TO MINIMAL LOADING CONDITIONS DURING USE. THE DAMAGE ON THE TANG IS CONSISTENT WITH THE INSERTION HANDLE BEING USED TO FORCE THE NAIL INTO POSITION IF THE ENTRY SITE IS SLIGHTLY MIS-LOCATED. BASED ON THE DETAILS PROVIDED, IT APPEARS THAT THE USER, TWISTED THE INSERTION HANDLE TO CORRECT THE ANGLE OF THE NAIL, WHICH WOULD INDICATE THAT THE ENTRY POSITION WAS MIS-LOCATED. TWISTING IN THIS MANNER COULD SIGNIFICANTLY INCREASE THE TORQUE APPLIED TO THE TANG WHICH COULD LEAD TO TWISTING, BENDING OR BREAKAGE AS NOTED IN THIS COMPLAINT. THERE IS A VERY SMALL PORTION OF THE TANG REMAINING ON THE RETURNED PART AND AT THE BASE OF IT ON ONE SIDE, THERE IS A CRACK RUNNING ACROSS THE FULL WIDTH OF THE BARREL. ALSO, THE FRACTURE FACE IS CONSISTENT WITH A SHEAR FAILURE IF THE TAB WAS SUBJECTED TO A SIGNIFICANT SIDE OR TORQUE LOAD. THEREFORE, IT IS LIKELY THAT THE COMPLAINT CONDITION IS DUE TO A MIS-LOCATED ENTRY POINT AND USING THE INSERTION HANDLE TO TRY TO CORRECT THE POSITION/ANGLE OF THE NAIL WHICH RESULTED IN EXCESSIVE TORQUE LOADING OF THE TANG. THE DESIGN IS ADEQUATE FOR THE INTENDED USE AND THE COMPLAINT CONDITION IS DUE TO DAMAGE CAUSED BY MIS-USE. THEREFORE THE COMPLAINT IS CONSIDERED INVALID FROM A MANUFACTURING PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LATERAL ENTRY FEMORAL NAIL PROCEDURE, THE SURGEON WAS DRIVING THE NAIL DOWN INTO THE BONE CANAL AND TWISTED THE INSERTION HANDLE TO CORRECT THE ANGLE OF THE NAIL. THE TAB AT THE JUNCTION OF THE NAIL AND THE INSERTION HANDLE BROKE OFF. THE BROKEN FRAGMENT WAS RETRIEVED. THE SURGEON USED ANOTHER INSERTION HANDLE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THE PATIENT WAS UNHARMED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149077 STANDARD INSERTION HANDLE LXH SYNTHES GMBH 1564982

    Patients

    Seq Age Sex Outcome Treatment
    1