BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPANDING HUMERAL INSERT TRIAL - SMALL 32MM STANDARD

    MDR report key: 3911997 · Received July 3, 2014

    Report

    Report Number
    0002249697-2014-02544
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWS
    PMA / PMN Number
    K130895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DIFFICULTY EXPANDING A RSA EXPANDING TRIAL WAS REPORTED. THE EVENT NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO DEVICE WAS RETURNED FOR INSPECTION. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT CONTRIBUTE TO THE EVENT. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO PRODUCT WAS RETURNED FOR INSPECTION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    EXPANDING TRIAL WAS DIFFICULT TO ASSEMBLE AND USE DURING SURGERY.

    Description of Event or Problem · 1

    UPDATE: IT WAS REPORTED THAT "THE SLIDE ON PLASTICE CANNOT BE SLID OUT ONCE THE SHOULDER IS REDUCED. UNFORTUNATELY, THE BACKSIDE OF THE PLASTIC TRAY CATCHES THE GLENOSPHERE AS IT'S TRYING TO SLIDE OUT. IT'S NOT LIKE TWO FLAT SURFACES SLIDING AGAINST EACH OTHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389563 EXPANDING HUMERAL INSERT TRIAL - SMALL 32MM STANDARD INSTRUMENT KWS STRYKER ORTHOPAEDICS-MAHWAH ER7TH3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other