BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTRAFIX TIBIAL SHEATH

    MDR report key: 526421 · Received April 29, 2004

    Report

    Report Number
    MW1032005
    Event Type
    Other
    Date Received
    April 29, 2004
    Date of Event
    March 31, 2004
    Report Date
    April 29, 2004
    Manufacturer
    LIFENET
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    POST OP INFECTION. RIGHT KNEE ARTHROSCOPIC ACL RECONSTRUCTION W/PATELLAR TENDON ALLOGRAFT. THIRTEEN DAYS LATER PT WAS RETURNED TO SURGERY FOR A RIGHT KNEE ARTHROSCOPY WITH WASHING AND DEBRIDEMENT.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 7/20/04: TRENDING AND ANALYSIS DID NOT REVEAL ANY OTHER INFECTION COMPLAINTS FOR THE ABOVE LOT NUMBERS. A REVIEW DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES OR PROBLEMS WITH THE ABOVE LOT NUMBERS. A REVIEW OF STERILITY RECORDS WAS PERFORMED AND DID NOT FIND OR IDENTIFY ANY PROBLEMS. PACKAGE SEAL TESTING RESULTS WERE ALSO REVIEWED AND RESULTS WERE WITHIN SPECIFICATIONS. NO EVALUATION FROM THE REPORTING FACILITY WAS PROVIDED TO DEPUY MITEK. THE PRODUCT WAS NOT RETURNED TO DEPUY MITEK AND THEREFORE CO CAN NOT PROVIDE ANY ROOT CAUSE ANALYSIS. DEPUY MITEK CONSIDERS THE ISSUE CLOSED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAFIX TIBIAL SHEATH ANTERIOR TIBIAL TENDON ALLOGRAFT (#1 OF 4) LMO LIFENET FANT/TIB/T (SIZE 8 0312172
    2 INTRAFIX TAPERED SCREW BONE MULCH SCREW (#2 OF 4) HRX ARTHROTEK INC. 907320 0308220
    3 INTRAFIX TAPERED SCREW (#3 OF 4) HWC MITEK WORLDWIDE ETHICON, INC. 254609 0308220
    4 INTRAFIX TIBIAL SHEATH (#4 OF 4) HWC MITEK WORLDWIDE ETHICON, INC. 254601 0312172

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other