BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3063340 · Received April 17, 2013

    Report

    Report Number
    2530088-2013-10422
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    September 20, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 THE HELICAL BLADE COUPLING SCREW WAS RECEIVED IN TWO PIECES 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 THREADS ON THE END ARE STILL INTACT AND A HELICAL BLADE WAS SUCCESSFULLY ATTACHED TO THE COUPLING SCREW. AS PREVIOUSLY NOTED, THE HELICAL BLADE COUPLING SCREW IS HAMMERED REPEATEDLY AS PART OF THE TECHNIQUE TO INSERT THE HELICAL BLADE. A REVIEW OF THE PRODUCT DESIGN/DRAWINGS ALSO 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, COULD RESULT IN LOADING CONDITIONS THAT MAY LEAD TO BREAKAGE. THE RETURNED DEVICE SHOWS EVIDENCE OF BEING USED/HAMMERED EXTENSIVELY. THE DENTS AROUND THE PERIMETER OF THE HEAD INDICATE THAT IT HAS BEEN STRUCK OFF-ANGLE NUMEROUS TIMES. THE DESIGN WAS REVIEWED AND DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE AND THEREFORE THE COMPLAINT IS CONSIDERED INVALID. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE COUPLING SCREW BROKE DURING HELICAL BLADE INSERTION. THE SURGEON USED THE BROKEN SCREW REMOVAL SET TO REMOVE THE BROKEN COUPLING SCREW, AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166219 HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 4566328

    Patients

    Seq Age Sex Outcome Treatment
    1