BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUNION TSA - MODULAR NECK ADAPTER TRIAL

    MDR report key: 3233671 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02368
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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

    DEVICE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY REVIEW NEITHER COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS A LOT WAS NOT PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY BIPOLAR TOTAL SHOULDER, SURGEON BROKE 2 OF THE SAME INSTRUMENTS. MODULAR NECK TRIAL ADAPTER BOTH WERE SHEARED OFF. SURGEON OPENED THE REAL COMPONENT AND TRIALED OFF OF THAT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY BIPOLAR TOTAL SHOULDER, SURGEON BROKE 2 OF THE SAME INSTRUMENTS. MODULAR NECK TRIAL ADAPTER BOTH WERE SHEARED OFF. SURGEON OPENED THE REAL COMPONENT AND TRIALED OFF OF THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333342 REUNION TSA - MODULAR NECK ADAPTER TRIAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other