BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER 2.5 I M PLUG 14MM

    MDR report key: 4424114 · Received January 15, 2015

    Report

    Report Number
    0002249697-2015-00134
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Date of Event
    December 19, 2014
    Report Date
    December 19, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K980843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 FOR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. -DEVICE HISTORY REVIEW: DHR REVIEW WAS SATISFACTORY. -COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED 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.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE EXETER INTRAMEDULLARY PLUG ALLEGEDLY BROKE DURING SURGERY AND THAT FRAGMENTS FELL INTO THE PATIENT. THE CUSTOMER FURTHER REPORTED THAT ALL THE FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE CUSTOMER REPORTED THAT THE ITEM WAS ON THE INTRODUCER AND WAS BEING LIGHTLY TAPPED IN AT THE TIME IT ALLEGEDLY BROKE. THE CUSTOMER ALSO REPORTED THAT THERE WAS MINIMAL DELAY AS AN ALTERNATIVE MANUFACTURED RESTRICTOR WAS USED TO COMPLETE SURGERY.

    Description of Event or Problem · 1

    UPDATE: THE PROCEDURE WAS FOR THE RIGHT HIP.THE CUSTOMER CONFIRMED THAT SOME FRAGMENTS REMAINED AFTER ATTEMPTS TO REMOVE THEM. THE CUSTOMER REPORTED THAT THE FEMUR WAS WASHED AND SUCTIONED TO REMOVE AS MUCH AS POSSIBLE THEN AN ALTERNATIVE JRI RESTRICTOR WAS IMPLANTED. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36222 EXETER 2.5 I M PLUG 14MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH L7164

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other