BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNALBRACE LIGAMENT

    MDR report key: 4220739 · Received November 3, 2014

    Report

    Report Number
    1220246-2014-00211
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. 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. A MOST LIKELY CAUSE OF THE EVENT IS AS STATED BY THE REPORTER THAT THE SURGEON FEELS IT WAS A TECHNIQUE RELATED ISSUE EITHER FROM INSERTING THE IMPLANT TOO DEEP OR MISSING THE PRE-DRILLED HOLE. 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. DEVICE WAS DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TALUS BONE WAS DRILLED AND TAPPED WITH A MALLET. AFTER INSERTION, WHEN THE SURGEON TESTED BY PULLING THE SUTURE, BOTH THE ANCHOR AND EYELET PULLED OUT OF THE HOLE. THE CASE WAS COMPLETED USING A BROSTRUM AND NOT THE INTERNAL BRACE (OPERATIVE TECHNIQUE ABANDONED). FOLLOW-UP: THE REP HAS SPOKEN TO THE SURGEON SINCE THIS PROCEDURE AND TO DATE THERE HAS NOT BEEN ANY FURTHER ISSUES REPORTED RELATED TO THIS INCIDENT. THE SURGEON DOES FEEL IT WAS A TECHNIQUE RELATED ISSUE, INSERTING THE IMPLANT TOO DEEP OR MISSING THE PRE-DRILLED HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701059 INTERNALBRACE LIGAMENT FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 1266355

    Patients

    Seq Age Sex Outcome Treatment
    1 Other