BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER 2.5 I M PLUG 10MM

    MDR report key: 3012663 · Received March 20, 2013

    Report

    Report Number
    0002249697-2013-01045
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K980843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INTRAOPERATIVE FRACTURE INVOLVING AN EXETER BONE PLUG WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE AN EXAMINATION OF THE REPORTED DEVICE IS NEEDED IN ORDER TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SURGERY, THE SURGEON ATTEMPTED TO INSERT THE INTRAMEDULLARY PLUG PRIOR TO STEM INSERTION. THE CUSTOMER FURTHER REPORTED THAT AS THE SURGEON REMOVED THE INTRODUCER, HE FOUND THAT THE PLUG HAD BROKEN. THE SURGEON WAS ABLE TO REMOVE ALL THE BROKEN PIECES BEFORE PROCEEDING. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SURGERY, THE SURGEON ATTEMPTED TO INSERT THE INTRAMEDULLARY PLUG PRIOR TO STEM INSERTION. THE CUSTOMER FURTHER REPORTED THAT AS THE SURGEON REMOVED THE INTRODUCER, HE FOUND THAT THE PLUG HAD BROKEN. THE SURGEON WAS ABLE TO REMOVE ALL THE BROKEN PIECES BEFORE PROCEEDING. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115443 EXETER 2.5 I M PLUG 10MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other