BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5

    MDR report key: 4945430 · Received July 28, 2015

    Report

    Report Number
    1219602-2015-00536
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    March 6, 2013
    Report Date
    July 16, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K113274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANCHOR BROKE OFF INTO THE PATIENT AND STAYED IN THE PATIENT'S BONE. ADDITIONAL 510(K) K093897. ONLY THE DELIVERY DEVICE WAS RETURNED FOR EVALUATION. THE PROXIMAL PORTION OF THE PEEK ANCHOR WAS NOT RETURNED. THE INNER DRIVER ADVANCED AND THE TORQUE LIMITER FUNCTIONED AS INTENDED. BASED ON PROVIDED EVIDENCE NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED SHOULDER ANTHROSCOPY PROCEDURE, THE ANCHOR BROKE OFF INTO THE PATIENT AND STAYED IN THE PATIENT'S BONE. IT WAS REPORTED THAT THE SURGEON PREPS THE SITE BY USING A 3.8 GOLD TAPER ALL. AFTER THE SURGEON IMPACTED THE ANCHOR , HE TRIED TO TIGHTEN THE GAS CAP TO MAKE SURE THE SUTURE WAS TIGHTEN TO THE ANCHOR AND THAT IS WHEN THE INCIDENT OCCURRED. THE SURGEON TRIED TO REMOVE THE BROKEN PIECE BUT WAS UNSUCCESSFUL. THE SURGEON SUCCESSFULLY COMPLETED THE PROCEDURE WITH A 5.5 DEVICE USING THE SAME OPENING. IT WAS CONFIRMED THAT THE SUTURES WERE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490209 FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5 FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 50445454

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R