BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TIGHTROPE RT

    MDR report key: 5745640 · Received June 23, 2016

    Report

    Report Number
    1220246-2016-00287
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 2, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTY
    PMA / PMN Number
    K112990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH) WERE REQUESTED BUT NOT PROVIDED. THIS IS ONE OF THREE SUBMISSIONS FROM THE SAME PATIENT EVENT. THE OTHERS ARE 1220246-2016-LINE 163295-00274 AND 1220246-2016-LINE 163347-002275. 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. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. 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. ANOTHER MANUFACTURER'S DEVICE ( AN ALLOGRAFT) WAS ALSO USED IN THE PROCEDURE AND FOR WHICH NO STERILIZATION INFORMATION IS AVAILABLE. THE MOST LIKELY CAUSE FOR THIS TYPE OF EVENT IS A NOSOCOMIAL SOURCE OR PATIENT NON-COMPLIANCE WITH POST-OP WOUND CARE DIRECTIONS. 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 THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE EXPECTED BUT NOT YET RETURNED,

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT INFECTION AFTER TWO YEARS POST-OP FROM AN ACL RECONSTRUCTION PROCEDURE. DURING THE SURGERY, THE GRAFT AND DEVICE(S) THAT WERE ORIGINALLY IMPLANTED WERE RETRIEVED. THE GRAFT WAS SENT FOR CULTURE LABORATORY TESTING. THE LABORATORY RESULTS REPORTED THE PRESENCE OF PSEUDOMONAS INFECTION AT THE END OF THE GRAFT SUTURE. THE GRAFT WAS RETRIEVED AND THE INFECTION HAS BEEN CONTAINED. FOLLOW-UP INVESTIGATION: THE ALLOGRAFT WAS NOT AN ARTHREX ALLOGRAFT, MANUFACTURER UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400174 ACL TIGHTROPE RT PIN, FIXATION, SMOOTH HTY ARTHREX, INC. 1189785

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other