BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSFIX IMPLANT

    MDR report key: 2701988 · Received August 16, 2012

    Report

    Report Number
    1220246-2012-00152
    Event Type
    Injury
    Date Received
    August 16, 2012
    Date of Event
    March 1, 2012
    Report Date
    July 18, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K062466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT; NO ISSUES WERE FOUND WITH THE STERILIZATION OF THIS LOT. THIS DEVICE IS SUPPLIED STERILE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE POST-OPERATIVE INFECTION COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE FOR THIS TYPE OF EVENT IS A NOSOCOMIAL SOURCE OR PATIENT NON-COMPLIANCE WITH POST-OP WOUND CARE DIRECTIONS. SCEDOSPORIUM PROLIFICANS IS A SOIL BASED FUNGI WITH HYPHAE THAT ARE SEPTATE WITH CONIDIOGENOUS CELLS THAT ARE OVOID IN SHAPE. THE SINGLE CELLED CONIDIA WALLS ARE THIN IN NATURE AND ARE POROUS TO MOST NATURED GAS MOLECULES (1) THESE CHARACTERISTICS CAUSE THE SCEDOSPORIUM PROLIFICANS TO BE SUSCEPTIBLE TO VARIOUS FORMS OF STERILIZATION. ETO GAS STERILIZATION EASILY PENETRATES THE CONIDIA AND CAUSES THE CELL TO BECOME INACTIVE. GAMMA RADIATION PENETRATES EASILY AND DUE TO LACK OF REVERSE DNA ENZYMES, REQUIRES A DOSING OF 1.3 -11 KGY TO YIELD THE CELL INACTIVE (2) IT CAN THEREFORE BE STATED THAT SCEDOSPORIUM PROLIFICANS DOES NOT PRESENT A SIGNIFICANT CHALLENGE TO THE STERILIZATION PROCESS. REFERENCES ATTACHED: (1) INFECTIONS CAUSED BY SCEDOSPORIUMSPP: CLIN. MICROBIAL. REV. 2008; 21(1):157 (2) GAMMA RADIATION AGAINST TOXIGENIC FUNGI IN FOOD, MEDICINAL AND AROMATIC HERBS; DR. ADOLPHO PINTO, HEALTH DEPARTMENT OF BRAZIL; CEP: 01156-050. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PER FACILITY, NOT RETURNING DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION WITH ONSET PAIN AND FEVER 7 DAYS POST SURGERY. THE PROCEDURE WAS A RIGHT KNEE ACL REPAIR WITH GRAFT. THE LAB RESULT WAS POSITIVE FOR SCEDOSPORIUM PROLIFICANS (FUNGUS). THREE I&D SURGERIES (INCISION AND DRAINAGE) WITH REMOVAL OF IMPLANT GRAFT. ANTIFUNGAL IV'S GIVEN. ONGOING ILLNESS MAY REQUIRE MORE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSFIX IMPLANT FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 393438

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other