BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER 2.5 I M PLUG 10MM

    MDR report key: 4844066 · Received June 15, 2015

    Report

    Report Number
    0002249697-2015-01935
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K980843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED DEVICE INVOLVING AN EXETER BONE PLUG WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW: DHR REVIEW WAS SATISFACTORY. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW CONFIRMED THAT THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. RETURN OF THE REPORTED DEVICE FOR EVALUATION IS REQUIRED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED THAT FRACTURE OF EXETER BONE PLUGS MAY RESULT FROM FACTORS SUCH AS ERRORS MADE DURING USE OR DESIGN FACTORS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS THE DEVICE WAS NOT RECEIVED BY STRYKER ORTHOPAEDICS. IF THE DEVICE BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY STRYKER SALES REP THAT THE PLUGS BROKE INSIDE A PATIENT'S FEMUR DURING A PROCEDURE UNDERGONE AT (B)(6) HOSPITAL. IT WAS CONFIRMED BY PHONE BY THE SALES REP THAT ALL THREE PLUGS REMAINED INSIDE THE PATIENT AND WILL NOT BE ABLE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY STRYKER SALES REP THAT THE PLUGS BROKE INSIDE A PATIENT'S FEMUR DURING A PROCEDURE UNDERGONE AT (B)(6) HOSPITAL. IT WAS CONFIRMED BY PHONE BY THE SALES REP THAT ALL THREE PLUGS REMAINED INSIDE THE PATIENT AND WILL NOT BE ABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388664 EXETER 2.5 I M PLUG 10MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH L7892

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other