BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWINFIX ULTRA - PK

    MDR report key: 3821495 · Received May 20, 2014

    Report

    Report Number
    1219602-2014-00157
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE TF ULTRA, 2 UBRAID AND NDLS, 4.5MM PK ANCHOR WAS RETURNED FOR EVALUATION OF THE REPORTED COMPLAINT MODE, ¿INFECTION¿. THERE WERE SMALL PIECES OF THE SUTURE RETURNED WITH THE ANCHOR AS WELL. BASED ON THE NATURE OF THE COMPLAINT, A REVIEW OF THE STERILITY RECORDS WAS CONDUCTED. THE PRODUCT WAS STERILIZED BY ETHYLENE OXIDE GAS ON (B)(4) 2013. ALL PROCESS PARAMETERS WERE CONFIRMED TO BE WITHIN SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE SURGEON PERFORMED AN ANTERIOR TALOFIBULAR LIGAMENT (ATFL) LIGAMENT REPAIR. THE HOLE WAS PREPPED USING A 3.8MM AWL DILATOR. THE SURGEON SUCCESSFULLY IMPLANTED ONE TWINFIX ULTRA PK 4.5MM SUTURE ANCHOR. NO OTHER DEVICES WERE IMPLANTED DURING THE INITIAL SURGERY. PATIENT WAS PLACED ON IV AND ORAL ANTIBIOTICS DURING THE OPERATION, IN THE WARDS AND POST-OPERATIVE UPON DISCHARGE. PATIENT WAS COMPLIANT WITH PHYSICIAN ORDERS AFTER THE INITIAL SURGERY (E.G. TAKING MEDICATIONS, LIMITING PHYSICAL ACTIVITY). PATIENT WENT FOR DAILY DRESSING & WEEKLY FOLLOW UP, STITCHES TAKEN OUT. THE WOUND WAS REPORTED TO HAVE BEEN RECOVERING WELL WITH ONLY MILD SWELLING. SUBSEQUENTLY, THE PATIENT DEVELOPED SYMPTOMS OF PAIN, REDNESS, AND SWELLING. THE WOUND WAS REPORTED TO BREAK DOWN. ON (B)(6) 2014, THE SURGEON REMOVED THE TWINFIX ULTRA PK 4.5MM SUTURE ANCHOR DUE TO OSTEOMYELITIS. NO ADDITIONAL DEVICES WERE PLACED DURING THE REVISION (REMOVAL OF IMPLANT) SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299790 TWINFIX ULTRA - PK TF ULTRA, 2 UBRAID AND NDLS, 4.5MM PK MBI MANSFIELD MANUFACTURING SITE 72202611 50459176

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention