BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR REAMER HANDLE

    MDR report key: 3120675 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01721
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING BREAKAGE INVOLVING AN ACETABULAR REAMER HANDLE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATIONS WERE PERFORMED BY THE VENDOR, WHO CONFIRMED THE REPORTED EVENT VIA VISUAL INSPECTION. THE DEVICE SHOWED SIGNS OF USE, WEAR, AND DAMAGE AND WAS UNREMARKABLE. THE EVENT WAS NOT RELATED TO A PATIENT OR SURGERY. DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE REPORTED LOT CODE. THE INVESTIGATION CONCLUDED THAT THE BREAKAGE WAS CAUSED BY WEAR OR DAMAGE DUE TO REPEATED INTENDED USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT SHOWED UP BROKEN IN THE TRAY. THE HUDSON CONNECTION WAS BROKEN OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT SHOWED UP BROKEN IN THE TRAY. THE HUDSON CONNECTION WAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222362 ACETABULAR REAMER HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH V11955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other