BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI TIGHTROPE REPAIR

    MDR report key: 4150796 · Received October 8, 2014

    Report

    Report Number
    1220246-2014-00184
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    January 1, 2013
    Report Date
    September 12, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    PMA / PMN Number
    K090107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THIS REPORT WAS PROVIDED BASED ON A PUBLISHED STUDY LITERATURE REVIEW. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS PATIENT NON-COMPLIANCE WITH THE POST-OP PROTOCOL. THE PRODUCT DIRECTIONS FOR USE STATES: POST-OPERATIVELY, UNTIL HEALING IS COMPLETE, THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POST-OPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE IMPLANT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PUBLISHED WHITE PAPER REPORT THAT THERE WAS A REVISION DONE FOR A POST-OPERATIVE SECOND METATARSAL FRACTURE ASSOCIATED WITH SUTURE-BUTTON IMPLANT IN A HALLUX VALGUS SURGERY. ALL PATIENTS WITH A STRESS FRACTURE WERE TREATED WITH A CAM WALKER. ONE PATIENT OUT OF 25 (4%) WITH A SECOND METATARSAL STRESS FRACTURE HAD A FAILURE OF THE IMPLANT THAT REQUIRED IMPLANT REMOVAL, AND AT THE TIME OF IMPLANT REMOVAL, A DISTAL CHEVRON OSTEOTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632703 MINI TIGHTROPE REPAIR WASHER, BOLT NUT HTN ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other