BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIFIT AXIAL REAMER

    MDR report key: 2990423 · Received March 5, 2013

    Report

    Report Number
    0002249697-2013-00907
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY COULD NOT BE PERFORMED BECAUSE THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED NOR WAS A VALID LOT CODE PROVIDED. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    DURING A SECURFIT HIP REPLACEMENT SURGEON FOUND AXIAL REAMERS TO BE BLUNT.

    Description of Event or Problem · 1

    DURING A SECURFIT HIP REPLACEMENT SURGEON FOUND AXIAL REAMERS TO BE BLUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92912 OMNIFIT AXIAL REAMER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other