BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3062801 · Received April 17, 2013

    Report

    Report Number
    2530088-2013-10405
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PRODUCT DEVELOPMENT EVALUATION STATED THAT THE HELICAL BLADE COUPLING SCREW WAS RECEIVED IN TWO PIECES AND WAS BROKEN WHERE THE KNOB AND SHAFT INTERSECT. THE SHAFT CONNECTION IS STILL WELDED INTO THE KNOB. THE FRACTURE SURFACE IS HOMOGENEOUS WHICH INDICATES MATERIAL UNIFORMITY. THERE ARE NUMEROUS DEEP DENTS ON THE TOP AND EDGES OF THE KNOB AND THERE ARE CIRCUMFERENTIAL SCRATCHES AROUND THE SHAFT JUST BELOW KNOB TO SHAFT JOINT. THE RETURNED DEVICE WAS MANUFACTURED IN DECEMBER 2007 AND IS OVER 4 YEARS OLD AND SHOWS EVIDENCE OF BEING USED-HAMMERED EXTENSIVELY OVER THAT TIME. THE DENTS AROUND THE PERIMETER OF THE HEAD INDICATE THAT IT HAS BEEN STRUCK OFF-ANGLE NUMEROUS TIMES. A REVIEW OF THE PRODUCT DESIGN/DRAWINGS SHOWED THE COUPLING SCREW DESIGN TO BE ACCEPTABLE FOR THE INTENDED USE. ADDITIONALLY, EXCESSIVE HAMMERING OF THE COUPLING SCREW OFF-ANGLE OR WHEN THE SCREW IS NOT FULLY TIGHTENED, PER THE TECHNIQUE GUIDE, IT COULD RESULT IN LOADING CONDITIONS THAT MAY LEAD TO BREAKAGE. IN CONCLUSION THE DESIGN WAS REVIEWED AND DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE AND THEREFORE THE COMPLAINT IS INVALID.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, TOWARDS THE END OF A TROCHANTERIC FIXATION NAIL (TFN)-LEFT PROCEDURE, THE HEAD OF A COUPLING SCREW SNAPPED OFF. PATIENT WAS NOT HARMED. INSTRUMENT IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165754 HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 5572040

    Patients

    Seq Age Sex Outcome Treatment
    1