BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 2964191 · Received February 15, 2013

    Report

    Report Number
    2530088-2013-00178
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 19, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE THREADS ON THE END OF THE RETURNED COUPLING SCREW ARE DISCOLORED BUT STILL INTACT AND A KNOWN GOOD HELICAL BLADE WAS ATTACHED TO THE COUPLING SCREW DURING THIS EVALUATION. THE HELICAL BLADE ONLY THREADED HALF WAY THE INTENDED LENGTH DUE TO THREAD DAMAGE ON THE RETURNED COUPLING SCREW. THE COMPLAINT CONDITION WAS REPLICATED DURING THIS EVALUATION. THERE ARE SEVERAL MINOR SURFACE SCRAPES AND SCUFFS ON THE SHAFT THAT ARE CONSISTENT WITH FIELD USE. THE HELICAL BLADE COUPLING SCREW IS HAMMERED REPEATEDLY AS PART OF THE TECHNIQUE TO INSERT THE HELICAL BLADE. A REVIEW OF THE TROCHANTERIC FIXATION NAIL DESIGN RISK ASSESSMENT CONFIRMED THAT THE ESTIMATED RISK LEVEL OF LESS SEVERE ADEQUATELY ASSESSES THE RISK OF THE COMPLAINT CONDITION WITH A MODERATE SEVERITY OF HARM 3 AND AN UNLIKELY PROBABILITY OF OCCURRENCE 2. SPECIFICALLY, THE 11TH HAZARD LISTED FOR THE 12TH LINE ITEM ADDRESSES THE INSERTER NOT MATING WITH 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 DESCRIBED TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM TECHNIQUE GUIDE, COULD RESULT IN LOADING CONDITIONS THAT MAY LEAD TO DAMAGE. THE RETURNED DEVICE WAS MANUFACTURED IN OCTOBER 2007 AND IS OVER 5 YEARS OLD AND SHOWS EVIDENCE OF BEING USED/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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A HIP FRACTURE SURGERY THE DOCTOR WAS INSERTING THE HELICAL BLADE COUPLING SCREW INTO THE HELICAL BLADE INSERTER, THE COUPLING SCREW STRIPPED. THE SURGEON WAS ABLE TO CONTINUE THE INSERTION USING THE SAME COUPLING SCREW. THE SURGERY WAS COMPLETED WITHOUT ANY ADDITIONAL PROBLEMS. NOTHING BROKE INTO OR FELL INTO THE WOUND. NO ADDITIONAL TIME IN THE OR WAS NEEDED. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66932 HELICAL BLADE COUPLING SCREW HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 5512103

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR