BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINCHLOCK KNOTLESS SUTURE ANCHOR 2.4MM

    MDR report key: 3123911 · Received May 15, 2013

    Report

    Report Number
    3007210693-2013-00006
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 14, 2013
    Manufacturer
    PIVOT MEDICAL
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVAL BUT WAS NOT RETURNED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT THE DEVICE FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWS THAT THE LOT FOR THE DEVICE ALLEGEDLY AT ISSUE MET MFR SPECS AND RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REFERENCING THIS LOT NUMBER. THIS WAS DETERMINED TO BE A REPORTABLE EVENT DUE TO THE PERMANENT NATURE OF THE ANCHOR THAT WAS LEFT IN THE PT, EVEN THOUGH NO INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE SURGEON ALLEGEDLY USED THE CINCHLOCK KNOTLESS ANCHOR FOR A HIP LABRUM REPAIR. THE SURGEON REPORTED THAT HE IMPLANTED THE FIRST TWO ANCHORS SUCCESSFULLY, THEN ON THE THIRD ANCHOR, HE BROKE ONE OF THE SUTURES WHILE APPLYING TENSION. THE SURGEON SAID HE THOUGHT THE SUTURE WAS HOLDING IN THE LABRUM, SO HE DEPLOYED THE ANCHOR AND THEN REMOVED THE INSERTER OUT, AT WHICH TIME HE OBSERVED THAT THE SUTURE WAS NOT HOLDING THE LABRUM, AND HE PULLED THE SUTURE OUT. THE ANCHOR STAYED IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215148 CINCHLOCK KNOTLESS SUTURE ANCHOR 2.4MM BONE ANCHOR HTW PIVOT MEDICAL 13031401

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR