BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 2840477 · Received November 20, 2012

    Report

    Report Number
    1719045-2012-01177
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED AND FOUND THAT THE LOCKING MECHANISM IS DEPLOYED AND THE LOCKING TAB IS BENT SIGNIFICANTLY TOWARD THE MEDIAL SIDE OF THE HELICAL BLADE HOLE. SCRATCHES AND WEAR MARKS EXIST ON THE TAB WHERE IT IS BENT. WEAR MARKS EXIST ON THE INSIDE OF THE NAIL WHERE THE HELICAL BLADE CONTACTED THE NAIL. MINOR WATER MARKS EXIST ON THE FLUTES OF THE NAIL. BASED ON EXAMINATION OF THE RETURNED PART, THE LOCKING MECHANISM IN THE NAIL WAS IN THE LOCKED POSITION WHEN ATTEMPTING TO INSERT THE HELICAL BLADE AND THE LOCKING TAB WAS BENT MEDIALLY AS A RESULT. A CAPA HAS BEEN INITIATED TO ADDRESS THIS ISSUE. THE RETURNED NAIL (PART 456.315S, LOT 7001854) WAS MANUFACTURED IN AUGUST 2012, AFTER THE IMPLEMENTATION OF CAPA (B)(4) CORRECTIVE ACTIONS WHICH INCLUDED THE USE OF A NEW END CAP, PM1844, TO SECURE THE LOCKING MECHANISM UNTIL THE DEVICE IS READY FOR USE. EVALUATION OF THE DESIGNS OF THE NAIL, LOCKING MECHANISM AND NEW END CAP (PM1844) SHOW THAT THE LOCKING MECHANISM IS ADEQUATELY SECURED AND ADVANCEMENT PREVENTED IF THE LOCKING MECHANISM DEPTH IS SET AS INTENDED AND THE END CAP INSERTED PROPERLY. THE DESIGN WAS EVALUATED AND THE POSITION OF THE LOCKING MECHANISM WILL BE SECURED AND INADVERTENT ADVANCEMENT PREVENTED IF PROPERLY ASSEMBLED. THE DESIGN IS ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE LOCKING MECHANISM IS DEPLOYED AND THE LOCKING TAB IS BENT SIGNIFICANTLY TOWARD THE MEDIAL SIDE OF THE HELICAL BLADE HOLE. SCRATCHES AND WEAR MARKS EXIST ON THE TAB WHERE IT IS BENT. WEAR MARKS EXIST ON THE INSIDE OF THE NAIL WHERE THE HELICAL BLADE CONTACTED THE NAIL. MINOR WATER MARKS EXIST ON THE FLUTES OF THE NAIL. LOCKING MECHANISM IS ADVANCED INTO THE TOP OF THE NAIL UNTIL THE GREEN LINE IS EVEN WITH THE TOP OF THE NAIL AND THE PROCESS SHEET CAUTIONS THE OPERATOR NOT TO BOTTOM OUT THE GAGE. WHEN INSERTED TO THE GREEN LINE, THE DEPTH WILL BE BETWEEN 9 AND 10 MM. AFTER ASSEMBLY AND REMOVAL OF THE INSERTION TOOL, THE END CAP IS INSERTED INTO THE TOP OF THE NAIL AND SNAPPED INTO THE LOCKING MECHANISM TO PREVENT THE LOCKING MECHANISM FROM SHIFTING OUT OF THE DEPTH RANGE. A 10.97 MM GAGE IS USED TO CONFIRM THAT THE LOCKING MECHANISM HAS NOT BEEN ADVANCED TO THE POINT THAT THE LOCKING PRONG EXTENDS INTO THE THROUGH HOLE FOR THE HELICAL BLADE. REVIEW OF THE PROCESS INDICATES THAT IT IS POSSIBLE TO INSERT THE LOCKING MECHANISM BEYOND THE TARGET DEPTH IF THE TOOL IS ADVANCED BEYOND THE GREEN LINE. IT ALSO APPEARS THAT IT IS POSSIBLE TO OVER-INSERT THE MECHANISM SUCH THAT THE BULB ON THE END OF THE END CAP WILL NOT PROPERLY ENGAGE THE LOCKING MECHANISM TO PREVENT INADVERTENT ADVANCEMENT WHILE HAVING THE LOCKING PRONG IN A POSITION THAT DOES NOT EXTEND INTO THE THROUGH HOLE AND WOULD NOT BE DETECTED USING THE 10.97 MM GAGE. REQUIRED INTERVENTION WAS MISTAKENLY SELECTED ON THE PRIMARY REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A TFN HIP FRACTURE PROCEDURE WHEREBY THE HELICAL BLADE WOULD NOT PASS THROUGH THE NAIL. IT WAS NOTED THAT THE SET SCREW DROPPED IN THE NAIL AND PREVENTED THE HELICAL BLADE TO PASS THROUGH. THE SURGEON REMOVED THE NAIL AND USED ANOTHER NAIL TO COMPLETE THE PROCEDURE. AS A RESULT, THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE TROCH FIXATION NAIL HSB SYNTHES MONUMENT 7001854

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention