BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAFIX (PEEK) SCREW , 8-10 X 30 MM

    MDR report key: 3932581 · Received July 14, 2014

    Report

    Report Number
    1221934-2014-00289
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K122123
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE REPORTED WAS FOR THE ASSOCIATED RIGIDLOOP BUTTON. THERE WAS NO FAILURE REPORTED WITH THE ORIGINAL INTRAFIX TIBIAL SHEATH & SCREW AND THEREFORE NO FURTHER EVALUATION IS REQUIRED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE, THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED ONE DISSIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTIONS ARE WARRANTED. HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    RIGIDLOOP BUTTON WAS FOUND TO BE IN THE FEMORAL TUNNEL WHEN A POST OP X-RAY WAS TAKEN AFTER ORIGINAL PRIMARY SURGERY ON THE LEFT LEG. AT TIME OF REVISION THE RIGIDLOOP WAS FOUND TO BE IN THE KNEE JOINT. THE TIBIAL IMPLANT WAS REMOVED AND A XL RIGIDLOOP WAS PLACED OVER A 30MM RIGIDLOOP BUTTON. ALL TUNNELS WERE RE REAMED AND THE ORIGINAL GRAFT WAS RETRIEVED AND RE USED FOR THE REVISION SURGERY. DUE TO HOSPITAL POLICY THERE ARE NO IMPLANTS TO BE RETURNED FOR EVALUATION. PATIENT IS MALE, (B)(6). ADDITIONAL INFORMATION FROM THE AFFILIATE (B)(4) 2014. WHAT WAS THE DATE OF THE ORIGINAL SURGERY? (B)(6) 2014. YOU STATED PRODUCT CODE 254601 254654 AND 232014 ON THE COMPLAINT FORM, WERE THEY USED ORIGINALLY? YES, THESE WERE USED IN THE PRIMARY SURGERY. WAS THE 30MM RIGIDLOOP BUTTON USED TO COMPLETE THE PROCEDURE? 30MM LOOP WITH A XL RIGIDLOOP BUTTON WAS USED IN THE REVISION PROCEDURE AFTER THE PATIENT WAS BROUGHT BACK TO THEATRES & THE GRAFT WAS REMOVED TO ALLOW FOR REMOVAL OF THE RIGIDLOOP WHICH WAS IN THE KNEE JOINT & THE GRAFT WAS NOT FIXED. THE GRAFT WAS THEN REPLACED INTO THE TUNNELS & IT WAS DETERMINED THAT THERE WOULD NEED TO BE EXTRA LENGTH ON THE FEMORAL LOOP TO ALLOW ADEQUATE FIXATION OF THE GRAFT LENGTH IN THE TIBIAL TUNNEL. CAN YOU VERIFY IF THE SURGEON FELT THE BUTTON WAS CORRECTLY PLACED (NO TISSUE SQUEEZED BETWEEN BUTTON AND BONE). IN THE PRIMARY SURGERY, HE THOUGHT IT WAS IN PLACE, THERE WAS NO COMMENT PASSED AT THE TIME OF PRIMARY SURGERY TO INDICATE THERE WERE ISSUES WITH THE FIXATION. THE GRAFT WAS TENSIONED FOR TIBIAL FIXATION. WHAT WAS THE ORIENTATION OF THE TUNNEL? DON¿T RECALL. DID THE SURGEON USE AM OR TT PORTAL FOR DRILLING THE FEMORAL TUNNEL? TRANSTIBIAL. WHEN WAS THE X-RAY DONE WHEN IT SHOWED THE BUTTON WAS IN THE TUNNEL? XRAY DONE WITHIN HOURS OF PRIMARY SURGERY AS PER SURGEON'S STANDARD PROTOCOL. ANY ANOTHER X-RAY BEFORE? DON¿T KNOW . WHAT WAS THE SIZE OF THE FEMORAL TUNNEL DRILLED? PRIMARY SURGERY 7MM REAMER & TUNNEL IN FEMUR & 4.5MM TUNNEL FOR RIGIDLOOP. SEE ASSOCIATED MEDWATCH # 1221934-2014-00288, 1221934-2014-00290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409231 INTRAFIX (PEEK) SCREW , 8-10 X 30 MM SOFT TISSUE ANCHOR, NON-BIODEGRADABLE MBI DEPUY MITEK NA 3654959

    Patients

    Seq Age Sex Outcome Treatment
    1