BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPANDING HUMERAL INSERT TRIAL - SMALL 40MM CONSTRAINED

    MDR report key: 4222219 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04127
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. A VISUAL INSPECTION CONFIRMS THE EVENT. THE POST OF THE PLASTIC TRIAL WAS COMPLETELY FRACTURED OFF. GOUGING WAS OBSERVED ALONG THE HELICAL LOCKING TRACT. THE DEVICE WAS DISCOVERED DURING INSPECTION; THERE WAS NO SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED EVENT. THIS EVENT MEETS THE DEFINITION OF PREVENTIVE MAINTENANCE. AN ANALYSIS OF THE RETURNED DEVICE FOUND THE DEVICE FRACTURED DUE TO A MULTIPLE IMPACT OVERLOAD CONDITION. NO MATERIAL OR MANUFACTURING DEFECTS. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    RESETTING TRAYS AND NOTICED TRIAL WAS STUCK ON BASEPLATE TRIAL. THE PLASTIC TRIAL BROKE WHEN I TWISTED IT OFF BASEPLATE. ON (B)(6) 2014: FURTHER CLARIFICATION FROM THE SALES REP INDICATED THAT THE TRIAL BECAME STUCK ON THE BASEPLATE DURING AN IN-SERVICE. UPON FURTHER MANIPULATION TO REMOVE THE TRIAL FROM THE BASEPLATE, IT BROKE. THE SALES REP CONFIRMED THAT IT DID NOT OCCUR DURING SURGERY.

    Description of Event or Problem · 1

    RESETTING TRAYS AND NOTICED TRIAL WAS STUCK ON BASEPLATE TRIAL. THE PLASTIC TRIAL BROKE WHEN I TWISTED IT OFF BASEPLATE. ON 10-13-2014: FURTHER CLARIFICATION FROM THE SALES REP INDICATED THAT THE TRIAL BECAME STUCK ON THE BASEPLATE DURING AN IN-SERVICE. UPON FURTHER MANIPULATION TO REMOVE THE TRIAL FROM THE BASEPLATE, IT BROKE. THE SALES REP CONFIRMED THAT IT DID NOT OCCUR DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703120 EXPANDING HUMERAL INSERT TRIAL - SMALL 40MM CONSTRAINED INSTRUMENT KWS STRYKER ORTHOPAEDICS-MAHWAH ER7TH8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other