BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 2781890 · Received October 11, 2012

    Report

    Report Number
    1719045-2012-01059
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTIONS NOTED A PORTION OF THE TIP WHICH COUPLES WITH THE REAMER HEAD HAS SHEARED OFF. THE TIP WAS NOT RETURNED FOR EVALUATION. HELIX HAS BEEN SIGNIFICANTLY WORN DOWN. THE HELIX LOCATED ABOVE THE HEX IS WORN DOWN WHICH CAUSED THE DRIVE SHAFT TO FAIL. THIS PORTION OF THE DEVICE WAS UPDATED. THE RIA DRIVE SHAFT HELIX COMPONENT CHANGED FROM STAINLESS STEEL 304 TO 316L WITH KOLSTERIZATION. THIS CHANGE IMPROVED THE RESISTANCE TO WEAR OF THE DRIVE SHAFT HELIX COMPONENT. DESIGN VERIFICATION TESTING WAS PERFORMED WHICH SHOWED THAT DRIVE SHAFT HELIX SAMPLES INCORPORATING THE DESIGN CHANGE PROPOSED SHOWED IMPROVEMENT IN WEAR RESISTANCE WHEN COMPARED TO THE PREVIOUS DESIGN AFTER EXPOSURE TO BENCH TESTING WHICH SIMULATE PRODUCT USE. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE INTENDED USE.

    Description of Event or Problem · 1

    A NON SYNTHES NAIL WAS REMOVED DUE TO INFECTION AND NON-UNION AND REPLACED WITH A TEMPORARY NON-SYNTHES ANTIBIOTIC NAIL BY THE SURGEON. ON (B)(6) 2012 THE SURGEON REMOVED THE TEMPORARY ANTIBIOTIC NAIL AND AT THAT TIME THE INFECTION WAS REPORTEDLY CLEARED. THE SURGEON THEN USED A RIA SYSTEM TO HARVEST AUTO-GRAFT. THE DRIVE SHAFT AND HEAD BROKE IN THE FEMORAL CANAL. ALL PARTS WERE IMMEDIATELY RETRIEVED. A NEW REAMER SHAFT AND HEAD WERE USED AND AN AUTO GRAFT WAS COLLECTED TO FILL THE VOID THE ANTIBIOTIC NAIL HAD LEFT. THE SURGEON IMPLANTED TFN AND LAG SCREW WITH NO FURTHER PROBLEMS. PATIENT REPORTEDLY RECOVERING WELL. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA DRIVE SHAFT HTO SYNTHES MONUMENT 6718729

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR REAMER HEAD