BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3062475 · Received April 17, 2013

    Report

    Report Number
    1719045-2013-10701
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    December 11, 2011
    Report Date
    December 11, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PLACEHOLDER.

    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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE HELICAL BLADE COUPLING SCREW WAS RECEIVED FOR A PRODUCT DEVELOPMENT EVALUATION IN TWO PIECES AND WAS BROKEN WHERE THE KNOB AND SHAFT INTERSECT. THE SHAFT CONNECTION WAS STILL WELDED INTO THE KNOB. THE FRACTURE SURFACE WAS HOMOGENEOUS WHICH INDICATED MATERIAL UNIFORMITY. THERE WERE NUMEROUS DEEP DENTS ON THE TOP AND EDGES OF THE KNOB AND THERE WERE CIRCUMFERENTIAL SCRATCHES AROUND THE SHAFT JUST BELOW KNOB TO SHAFT JOINT. THE THREADS ON THE END WERE STILL INTACT AND A HELICAL BLADE WAS SUCCESSFULLY ATTACHED TO THE COUPLING SCREW. AS NOTED IN PREVIOUS INVESTIGATIONS, THE HELICAL BLADE COUPLING SCREW IS HAMMERED REPEATEDLY AS PART OF THE TECHNIQUE TO INSERT THE HELICAL BLADE. EXCESSIVE HAMMERING OF THE COUPLING SCREW OFF-ANGLE OR WHEN THE SCREW IS NOT FULLY TIGHTENED, PER THE DESCRIBED TECHNIQUE, COULD RESULT IN LOADING CONDITIONS THAT MAY LEAD TO BREAKAGE. THE RETURNED DEVICE WAS MANUFACTURED IN MAY 2007, WAS OVER 4 YEARS OLD AND SHOWS EVIDENCE OF BEING USED EXTENSIVELY OVER THAT TIME. THE DENTS AROUND THE PERIMETER OF THE HEAD INDICATED THAT IT HAS BEEN STRUCK OFF-ANGLE NUMEROUS TIMES. THE DESIGN WAS REVIEWED AND DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE. THEREFORE, THE COMPLAINT IS INVALID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL PROCEDURE, WHEN THE SURGEON WAS MALLETING THE HELICAL BLADE COUPLING SCREW, THE KNOB BROKE OFF. IT DID NOT FALL INTO THE WOUND. THE SURGEON CONTINUED TO MALLET THE COUPLING SCREW TO GET THE HELICAL BLADE INTO THE CORRECT PLACEMENT. HE THEN USED THE CONICAL EXTRACTION SCREW TO REMOVE THE COUPLING SCREW. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. THIS REPORT IS FOR (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166174 HELICAL BLADE COUPLING SCREW LXH SYNTHES MONUMENT 5448790

    Patients

    Seq Age Sex Outcome Treatment
    1