BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 2962854 · Received February 14, 2013

    Report

    Report Number
    2530088-2013-10095
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 9, 2012
    Report Date
    January 10, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE HELICAL BLADE COUPLING SCREW WAS RECEIVED 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 HOMOGENOUS, WHICH INDICATES 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. 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 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 NOVEMBER 2005 AND IS OVER 6 YEARS OLD AND SHOWS EVIDENCE OF BEING USED OR HAMMERED EXTENSIVELY OVER THAT TIME. 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 INVALID WITH RESPECT TO DESIGN. ORIGINAL AWARENESS DATE IS (B)(6) 2012. NEW INFORMATION WAS RECEIVED (B)(6) 2012.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERTROCHANTERIC NAILING, THE NUT BROKE FROM THE SHAFT OF THE HELICAL BLADE COUPLING SCREW. SALES CONSULTANT HAD A BACK UP SET THAT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PATIENT WAS NOT HARMED. SCREW IS AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64449 HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 4984967

    Patients

    Seq Age Sex Outcome Treatment
    1