BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM

    MDR report key: 2053654 · Received March 17, 2011

    Report

    Report Number
    9610622-2011-00114
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 1, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DIMENSIONAL EXAMINATION - DIMENSIONAL EXAMINATION REVEALED NO DEVIATIONS IN THE RELEVANT UNDAMAGED AREAS. FUNCTIONAL CHECK - THE FUNCTIONAL CHECK REVEALED THAT THE MIS-TARGETING OF THE DEVICE IS NOT AFFECTED BY THE LOOSEN METAL PART. DUE TO FORMER COMPLAINTS WE KNOW THAT THIS MIS-TARGETING IS THE RESULT OF THE DEFORMED CFR-MATERIAL DUE TO HIGH NUMBER OF STERILIZATION CYCLES. REVIEW OF DEVICE HISTORY RECORD (DHR) - A REVIEW OF THE INSPECTION RECORDS FOR THE TARGETING ARM (ENGRAVED LOT CODE KP225176/KHI0517) REVEALED NO DISCREPANCIES. THE ITEM WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THE INSTRUMENT WILL INEVITABLY SUFFER FROM LONG AND FREQUENT USE. AS THE RETURNED TARGETING ARM HAD BEEN IN USE FOR A LONGER TIME (APPROXIMATELY 6.5 YEARS) WE PRE-SUPPOSE THAT THE DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. DUE TO FACT OF THE AGE OF THE DEVICE (OVER 6.5 YEARS) AND THE RESULTING HIGH NUMBER OF STERILIZATION CYCLES GIVEN ON THE INSTRUMENT WE ASSUME THAT THIS FACTS ARE THE ROOT CAUSE OF THE LOOSEN METAL PART. WE REGARD THIS DAMAGE AS WEAR AND TEAR OF THE INSTRUMENT.

    Description of Event or Problem · 1

    THE NURSE REPORTED VIA OUR SALES REP THAT THE METAL PART OF THE DEVICE LOOSENED FROM THE CARBON PART AND CAN BE MOVED. ALSO, AN ALTERNATIVE DEVICE WAS AVAILABLE AND THE SURGERY WAS EXECUTED WITHOUT DELAY AND FINISHED WITH DESIRED RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGETING ARM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP225176

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other