BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 2922816 · Received January 18, 2013

    Report

    Report Number
    2530088-2013-00050
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    JDS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THERE WERE MINOR SCRATCHES, DENTS AND WEAR MARKS EXIST (THROUGH THE ANODIZE LAYER EXPOSING THE BASE MATERIAL) ON THE RETURNED DEVICE. THE BUTTON THAT CAPTURES AND RELEASES THE COMPRESSION/BUTTRESS NUT COMPONENT, FUNCTIONS AS INTENDED. DURING THE EVALUATION, THE RETURNED DEVICE (AIMING ARM) WAS ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS AND IMPLANTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE FUNCTION OF THE RETURNED DEVICE. THE MATING KNOWN GOOD PARTS INCLUDED A CANNULATED CONNECTING SCREW, TROCHANTERIC FIXATION NAIL, BLADE GUIDE SLEEVE, COMPRESSION /BUTTRESS NUT, INSERTION HANDLE, AND BALL HEX SCREWDRIVER. THE CONSTRUCT ASSEMBLED AND THE RETURNED AIMING ARM CAPTURED AND RELEASED THE BUTTRESS NUT AS INTENDED. THERE WERE NO RETAINMENT ISSUES EXPERIENCED DURING THIS EVALUATION, THEREFORE THE COMPLAINT CONDITION COULD NOT BE REPLICATED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE FOR AN INTERTROCHANTERIC FRACTURE, THE SURGEON PUT THE GUIDE PIN INTO THE FEMORAL HEAD AND MEASURED THROUGH THE BLADE GUIDE SLEEVE, SET THE STEP REAMER AND SELECTED THE HELICAL BLADE. WHEN THE SURGEON PUT THE BLADE IN, THE BLADE WAS TOO LONG. APPARENTLY THE BLADE GUIDE SLEEVE SLIPPED THROUGH THE ANGLE GUIDE WHICH WAS SUPPOSED TO LOCK THE BLADE GUIDE SLEEVE. THE SURGEON REMOVED THE BLADE, SELECTED A SHORTER ONE, AND COMPLETED THE PROCEDURE. PROCEDURE WAS EXTENDED APPROXIMATELY 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27420 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS AIMING ARM JDS SYNTHES BRANDYWINE 4761924

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR