BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3082278 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10554
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION, VISUAL INSPECTION REPORT STATED THAT THE KNURLED KNOB IS SHEARED FROM THE SHAFT AT THE JUNCTION WHERE THE SHAFT ENTERS THE KNOB. THE CONTACT SURFACE ON THE UNDERSIDE OF THE KNOB THAT SEATS AGAINST THE MATING SURFACE OF THE INSERTER IS DEFORMED AND DISCOLORED WITH WHAT APPEARS TO BE RUST. THE OPPOSITE SIDE OF THE KNOB (HAMMER IMPACT SIDE) EXHIBITS A HAMMERED SURFACE. A CONICAL EXTRACTION SCREW (P/N 387.34, LOT# U131212) ALSO ACCOMPANIED THIS COMPLAINT. THE TAPERED THREADS ARE SLIGHTLY DEFORMED ABOUT 14MM FROM THE TIP OF THE DEVICE. THE DESIGN EVALUATION REPORT STATED THE SUBJECT DEVICE HAS BEEN DESIGNED TO BE SUBJECTED TO NUMEROUS HAMMER BLOWS AND WITH ALL DEVICES THEY HAVE A MAXIMUM FATIGUE CYCLE LIFE. OTHER CONDITIONS CAN CAUSE THE SAME MODE OF FAILURE; I.E. HAMMERING OFF AXIS AND HAMMERING WHEN THE CONNECTING SCREW IS LOOSE. PER THE LOT NUMBER THIS DEVICE SEEMS TO HAVE BEEN IN SERVICE SINCE DECEMBER 2007. COMPLAINTS HAVE BEEN REPORTED WITH THIS CONDITION SINCE THE INCEPTION OF THE DEVICE AND IS A KNOW FAILURE MODE. WHEN THIS FAILURE OCCURS THE CASE CAN BE CONTINUED UNTIL THE HELICAL BLADE IS SEATED. THE SURGEON WILL THEN NEED TO USE ONE OF THE CONICAL EXTRACTION SCREWS (387.34 OR 309.520) FROM THE SCREW REMOVAL SET TO UNSCREW THE CONNECTING SCREW SHAFT AND RETRIEVE THE BROKEN FRAGMENT AS WAS DONE IN THIS PARTICULAR INSTANCE. SINCE THIS IS A RECOGNIZED FAILURE MODE THE COMPLAINT IS VALID BUT DEEMED AS A LOW RISK SITUATION THE COMPLAINT DOES NOT NEED FURTHER EVALUATION. RISK ASSESSMENT FILE WAS REVIEWED AND IT DOES ADEQUATELY ADDRESS THIS TYPE OF EVENT. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS HITTING THE BACK END OF THE COUPLING SCREW WITH A MALLET TO INSERT THE HELICAL BLADE AS PER THE TECHNIQUE GUIDE. THE PART OF THE COUPLING SCREW THAT RECEIVES THE IMPACT BROKE OFF AND FELL ON THE FLOOR. THE SURGEON CONTINUED THE PROCEDURE BY HITTING THE BACK END OF THE HELICAL BLADE INSERTER TO DO THE FINAL SEATING OF THE IMPLANT. THEN, THE SURGEON USED A CONICAL EXTRACTION DEVICE TO UNSCREW THE REMAINING SHAFT OF THE COUPLING SCREW FROM THE SHAFT FROM THE BLADE. THE PROCEDURE WAS DELAYED APPROXIMATELY FIVE MINUTES. THE SURGEON WAS SATISFIED WITH THE RESULTS. EVENT #1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183702 HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 5512103

    Patients

    Seq Age Sex Outcome Treatment
    1