BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-PUSHLOCK 3.5MM X 14MM

    MDR report key: 1061716 · Received June 13, 2008

    Report

    Report Number
    1220246-2008-00109
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED ONLY ONE OF THE DRIVERS FOR EVAL, THE EYELET OF THE DEVICES REMAIN IN THE PT. THE DRIVER RETURNED MET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE CAUSE OF THE COMPLAINANT'S EVENT COULD NOT BE DETERMINED WITHOUT EVAL OF THE ACTUAL EYELETS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (LEFT SHOULDER) THE SURGEON HAD PASSED 4 SUTURE STRANDS THROUGH THE PEEK EYELETS AND THE EYELET OF TWO DEVICES BROKE (SPLIT). ONE OF THE ANCHORS WAS LEFT OVER THE EYELET IN THE BONE AND THE OTHER ONE WAS REMOVED LEAVING ONLY THE EYELET IN THE BONE. NO FURTHER PT INFO IS AVAILABLE AND NO ADD'L ADVERSE CONSEQUENCES WERE REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-PUSHLOCK 3.5MM X 14MM BIO-ABSORBABLE IMPLANT MAI ARTHREX, INC. NA 142263

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other