BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR HANDLE

    MDR report key: 3984196 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03009
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING THE DISASSEMBLY OF A TRIATHLON HANDLE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: INSPECTION OF THE RETURNED DEVICE CONFIRMS THE EVENT AS THE DEVICE WAS RETURNED WITH THE BODY, SHAFT, SPRING, AND DOWEL PIN DISASSOCIATED FROM THE BODY OF THE DEVICE. THE PIN WAS NOT RETURNED. MATERIAL ANALYSIS CONCLUDED THAT NO PRESS-FIT WAS OBSERVED IN THE HOLE OF THE SHAFT. MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAS BEEN THREE OTHER EVENTS FOR THE LOT REFERENCED.. CONCLUSIONS: A CAPA WAS INITIATED DUE TO A SERIES OF COMPLAINTS RECEIVED REGARDING THE A LACK OF PRESS-FIT OF THE SHAFT HOLE OF TRIATHLON HANDLES. THIS EVENT WAS DETERMINED TO BE UNDER THE SCOPE OF THE CAPA . THE INVESTIGATION AT THE SUPPLIER CONCLUDED THAT THE ISSUE WAS TIED TO OPERATORS PERFORMING AN OVER-REAMING OF THE COUNTER BORE FEATURE, WHICH MATES UP TO THE PRESS FIT PIN, PART #9000-8-326. THIS OVER-REAMING, RESULTED IN A DIMINISHED PRESS FIT LENGTH OF THE HOLE, FURTHER RESULTING IN A PIN THAT COULD COME LOOSE AND THE ASSEMBLY FALLING APART.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SURGEON WAS MAKING HIS FEMORAL CUTS WITH THE 4 IN 1 CUTTING GUIDE. THE MODULAR HANDLE LISTED ABOVE CAME APART. THE MODULAR HANDLE WAS ENGAGED IN THE CUTTING BLOCK AT THE TIME AND BEING HELD BY AN ASSISTANT. A C ARM WAS ORDERED BECAUSE WE COULD NOT FIND THE CONTAINMENT PEG AND IT WAS FEARED THAT IT FELL INTO THE WOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SURGEON WAS MAKING HIS FEMORAL CUTS WITH THE 4 IN 1 CUTTING GUIDE. THE MODULAR HANDLE LISTED ABOVE CAME APART. THE MODULAR HANDLE WAS ENGAGED IN THE CUTTING BLOCK AT THE TIME AND BEING HELD BY AN ASSISTANT. A C ARM WAS ORDERED BECAUSE WE COULD NOT FIND THE CONTAINMENT PEG AND IT WAS FEARED THAT IT FELL INTO THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460865 MODULAR HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH SB1N02

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other