BEUDAMED
    FDA Adverse Event Summary report: N

    MOVATION KNEE INSTRUMENT

    MDR report key: 3012842 · Received March 20, 2013

    Report

    Report Number
    1644408-2013-00164
    Date Received
    March 20, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS COMPLAINT WAS REPORTED AS HOLES THAT PUNCTURED IN THE STERILE WRAP TO BRACKETS ON THE BOTTOM OF THE STERILITY TRAY. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS A DELAY OF ONE HOUR IN SURGERY AND ANOTHER SUITABLE DEVICE WAS NOT AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS A LOANER INSTRUMENT TRAY AND WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE FIRST COMPLAINT FOR THIS INSTRUMENT CASE. THE ROOT CAUSE FOR THIS COMPLAINT IS THE STERILE WRAPS WERE DAMAGED AFTER BEING WRAPPED AROUND THE 800-99-061 INSTRUMENT TRAY. FACTORS THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT INCLUDE: SLIDING THE INSTRUMENT TRAY, PLACING HEAVY OBJECTS (LIKE OTHER INSTRUMENT TRAYS) ON TOP OF THE WRAPPED TRAY, OR WRAPPING THE TRAY TOO TIGHTLY. THERE HAS BEEN NO EVIDENCE THAT A DESIGN OR MANUFACTURING PROBLEM CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    PRIMARY SURGERY - HOLES WERE PUNCTURED IN THE STERILE WRAP DUE TO THE BRACKETS ON THE BOTTOM OF THE STERILITY TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114982 MOVATION KNEE INSTRUMENT SURGICAL INSTRUMENT TRAY LPH ENCORE MEDICAL, L.P. 568P1001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other