BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER RASP SIZE 0 37.5MM

    MDR report key: 2155332 · Received June 28, 2011

    Report

    Report Number
    2249697-2011-00962
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE TRUNNION OF THE EXETER MODULAR RASP BROKE DURING AN ATTEMPT TO REMOVE THE INSTRUMENT FROM THE BONE AFTER TRIAL REDUCTION. THE TIP OF THE TRUNNION DISASSOCIATED FROM THE RASP AND REMAINED IN THE RASP HANDLE. REPEATED ATTEMPTS TO REMOVE THE RASP FAILED AND IT REMAINS IN THE PATIENT UNTIL A REVISION SURGERY IS DONE, DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER RASP SIZE 0 37.5MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other