BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3022677 · Received March 27, 2013

    Report

    Report Number
    2530088-2013-10274
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    April 26, 2012
    Report Date
    April 26, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 IN TWO PIECES AND WAS BROKEN WHERE THE KNOB AND SHAFT INTERSECT. THE FRACTURE SURFACE WAS HOMOGENOUS WITH A CONTINUOUS WELD BEAD WHICH INDICATED MATERIAL UNIFORMITY AND GOOD WELD PENETRATION. THE SHAFT CONNECTION WAS STILL WELDED INTO THE KNOB, BUT THERE WAS A HAIRLINE CRACK AROUND APPROXIMATELY HALF THE CIRCUMFERENCE. THERE WERE NUMEROUS DENTS ON THE TOP AND EDGES OF THE KNOB. THE THREADS ON THE END WERE STILL INTACT AND A HELICAL BLADE WAS SUCCESSFULLY ATTACHED TO THE COUPLING SCREW. THERE WERE SEVERAL MINOR SURFACE SCRAPES AND SCUFFS ON THE SHAFT THAT ARE CONSISTENT WITH FIELD USE. PRODUCT DEVELOPMENT EVALUATION DETERMINED THAT, AS NOTED IN PRIOR COMPLAINTS, THE HELICAL BLADE COUPLING SCREW IS HAMMERED REPEATEDLY AS PART OF THE TECHNIQUE TO INSERT THE HELICAL BLADE. A REVIEW OF THE PRODUCT DESIGN AND 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 DESCRIBED TECHNIQUE, COULD RESULT IN LOADING CONDITIONS THAT MAY LEAD TO BREAKAGE. THE RETURNED DEVICE WAS MANUFACTURED IN OCTOBER 2005 AND IS OVER 6 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. PER THE EVALUATIONS PERFORMED, THE COMPLAINT IS INVALID WITH RESPECT TO DESIGN.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE SURGEON IMPLANTED THE TROCHANTERIC FIXATION NAIL HELICAL BLADE, WHILE DISCONNECTING THE HELICAL BLADE COUPLING SCREW, THE BACK END WHERE THE SCREWDRIVER IS INSERTED POPPED OFF. THE BROKEN FRAGMENT WAS RETRIEVED. PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT.

    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
    125096 HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 5010025

    Patients

    Seq Age Sex Outcome Treatment
    1