BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-CHANGE III CONNECTOR

    MDR report key: 4551350 · Received February 26, 2015

    Report

    Report Number
    0002249697-2015-00479
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    January 30, 2015
    Report Date
    January 30, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING AN ASSEMBLY ISSUE INVOLVING AN X-CHANGE III CONNECTOR WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: INSPECTION WAS PERFORMED BY THE SUPPLIER, LISI MEDICAL. VISUAL INSPECTION: THERE ARE SOME MARKS OF USE ON THE TWO INSTRUMENTS. THE END OF THE CONNECTOR THAT CONNECTS TO THE SLIDING HAMMER IS DAMAGED AND DEFORMED, CONSISTENT WITH USE AND POSSIBLE MIS-USE E.G. IF A SURGEON HAD USED THE CONNECTOR WITHOUT THE SLIDING HAMMER. DIMENSIONAL INSPECTION WAS PERFORMED ON THE END OF THE CONNECTOR THAT CONNECTS TO THE SLIDING HAMMER. THE DIAMETER WAS FOUND TO BE TOO LARGE, CONSISTENT WITH USE AND POSSIBLE MIS-USE E.G. IF A SURGEON HAD USED THE CONNECTOR WITHOUT THE SLIDING HAMMER. FUNCTIONAL TEST WAS PERFORMED WITH THE TWO RETURNED INSTRUMENTS, IT IS NOT POSSIBLE TO CONNECT THE TWO INSTRUMENTS TOGETHER AS THE END OF THE CONNECTOR IS TOO LARGE. SUPPLIER EVALUATION: LISI MEDICAL ORTHOPAEDICS (LMO), CONDUCTED AN INVESTIGATION AND CONCLUDED THAT THE TWO RETURNED INSTRUMENTS CANNOT BE ASSEMBLED BECAUSE THE END OF THE CONNECTOR IS DIMENSIONALLY TOO LARGE AS IT WAS DAMAGED AND DEFORMED DURING USE, POSSIBLY IN A PREVIOUS SURGERY. A SURGEON MAY HAVE USED THE CONNECTOR WITHOUT THE SLIDING HAMMER. HE MAY HAVE PERFORMED THE IMPACTION DIRECTLY WITH A HAMMER. -MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT BRIEF DESCRIPTION WAS CAUSED BY DAMAGE CONSISTENT WITH SERVICE AND POSSIBLY MIS-USE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTOR AND SLIDE HUMMER COULD NOT BE ASSEMBLED IN THE MEDICAL PROCEDURE. THE SURGEON IMPACTED WITH ANOTHER TOOL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTOR AND SLIDE HUMMER COULD NOT BE ASSEMBLED IN THE MEDICAL PROCEDURE. THE SURGEON IMPACTED WITH ANOTHER TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136180 X-CHANGE III CONNECTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G3016629

    Patients

    Seq Age Sex Outcome Treatment
    1 Other