BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT CERAMIC INST RMVL TOOL

    MDR report key: 3781170 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01668
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K123604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAS BEEN ONE OTHER EVENT FOR THE REPORTED LOT. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE TRIDENT CERAMIC INST RMVL TOOL WAS USED TO REMOVE A COMPETITOR'S IMPLANT. THIS USE IS NOT SANCTIONED BY STRYKER AND AS SUCH IS CONSIDERED AN OFF LABEL APPLICATION OF THE DEVICE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COMPETITOR REMOVAL AND STRYKER IMPLANTATION THE SURGEON USED INSTRUMENT TO REMOVE THE METAL INSERT FROM THE HEAD AND THE INSTRUMENT BROKE. DID NOT CAUSE ANY DELAY IN SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COMPETITOR REMOVAL AND STRYKER IMPLANTATION THE SURGEON USED INSTRUMENT TO REMOVE THE METAL INSERT FROM THE HEAD AND THE INSTRUMENT BROKE. DID NOT CAUSE ANY DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260739 TRIDENT CERAMIC INST RMVL TOOL INSTRUMENT MAY STRYKER ORTHOPAEDICS-MAHWAH FWK177

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other