BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAPE ARM

    MDR report key: 2051774 · Received March 16, 2011

    Report

    Report Number
    2031963-2011-00012
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA EXISTS. THE SERIAL NUMBER WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. FURTHER ATTEMPTS FOR THIS INFO WILL BE MADE. THERE IS NO EXP DATE FOR THIS PRODUCT. DEVICE HAS NOT BEEN EVALUATED BY A STRYKER REP AT THIS TIME OF THIS REPORT. THE CUSTOMER HAD NOT AUTHORIZED ON-SITE EVAL OR REPAIR AT THE TIME OF THIS REPORT. INITIAL REPORTER'S OCCUPATION WAS NOT KNOWN AT THE TIME OF THIS REPORT. FURTHER ATTEMPTS FOR THIS INFO WILL BE MADE. EVAL SUMMARY: THIS MALFUNCTION WAS REPORTED BY A COMPANY REP, AND IMAGES OF THE PRODUCT WERE PROVIDED. BASED ON THE IMAGES, THERE APPEARS TO BE FLAKES OF DEBRIS AT THE LOCATION OF THE PIVOT JOINT FOR THE SHAPE ARM. IN ADDITION, THERE IS ALSO A NOTICEABLE LEAN OF THE SHAPE ARM AT THE MAIN PIVOT JOINT LOCATION. THE CUSTOMER HAS NOT AUTHORIZED ON-SITE EVAL OR REPAIR AT THE TIME OF THIS REPORT, AND THUS THE ROOT CAUSES OF THESE MALFUNCTIONS ARE UNK. HOWEVER, BASED ON THE INFO KNOWN AT THIS TIME, THERE IS NOT ENOUGH INFO TO RULE OUT THE POTENTIAL HEALTH RISK FROM DEBRIS FALLING INTO THE STERILE FIELD, OR RULE OUT THE POTENTIAL HEALTH RISK FROM THE LEANING SHAPE ARM AND IF THIS MALFUNCTION INDICATES THE POTENTIAL FOR THE SHAPE ARM TO DETACH. HOWEVER, THESE MALFUNCTIONS WERE IDENTIFIED PRIOR TO USE AND NO PTS WERE INVOLVED AND NO ADVERSE EVENTS WERE REPORTED. THIS TYPE OF NON-CONFORMANCE WILL BE MONITORED FOR ADVERSE TRENDS. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT A BAM ARM (WHICH IS ALSO KNOWN AS A SHAPE ARM) HAS A BROKEN MAIN JOINT. AFTER IMAGES WERE PROVIDED, IT WAS ALSO NOTICED THAT THERE IS DEBRIS AT THE LOCATION OF THE PIVOT JOINT FOR THE SHAPE ARM. THERE WAS NO REPORTED PT INVOLVEMENT, AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHAPE ARM BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA