BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT SPS

    MDR report key: 2801764 · Received October 23, 2012

    Report

    Report Number
    1020279-2012-00572
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICES WERE CONTAINED AND RE-PROCESSED. OUR INVESTIGATION CONCLUDED THAT THE DEVICES WERE NOT STERILIZED PRIOR TO DELIVERY. NO AFFECTED DEVICES ARE IN THE FIELD. OUR INVESTIGATION RESULTED IN A CORRECTIVE ACTION REQUEST FOR EXPRESS IMPLANTS. THIS ISSUE WAS ALSO COMMUNICATED TO OUR CAPA TEAM THROUGH INTERNAL PROCEDURES. APPROPRIATE CORRECTIONS/ CORRECTIVE ACTIONS WILL BE IDENTIFIED BY CAPA AND IMPLEMENTED TO PREVENT REOCCURRENCE OF THIS FAILURE IN THE FUTURE.

    Description of Event or Problem · 1

    THE STERILITY OF THE DEVICES WERE QUESTIONED JUST PRIOR TO SURGERY. PATIENT HAD BEEN PREPPED AND ANESTHESIA ADMINSTERED WHEN THE SURGERY HAD TO BE CANCELLED/ POSTPONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT SPS 2MM OFFSET COUPLER JWH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)