BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTPRINT PEEK 4.5 M

    MDR report key: 1941445 · Received December 29, 2010

    Report

    Report Number
    1219602-2010-00323
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    October 29, 2010
    Report Date
    December 3, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE INSERTER WAS RETURNED FOR EVALUATION. TORQUE LIMITER KNOB ROTATES WITHOUT ISSUE. WITHOUT THE RETURN OF THE ANCHOR IT CANNOT BE DETERMINED WHY THIS INCIDENT OCCURRED.(B)(4)

    Description of Event or Problem · 1

    DR. WAS DOING A ROTATOR CUFF REPAIR; PREPARED HOLE WITH TAPERED AWL TO LASER LINE. BONE QUALITY NOTED WAS GOOD, BUT NOT TOO SOFT. SUTURES WERE THREADED INTO THE ANCHOR AS PER TECHNIQUE AND SLID THROUGH. ANCHOR WAS INSERTED AS PER TECHNIQUE. WHEN ATTEMPTING TO TIGHTEN SUTURES, THEY WOULD NOT PULL THROUGH THE ANCHOR. TRIED REVERSING THE TORQUE LIMITER, TO NO AVAIL. WHEN MORE TENSION WAS PLACED ON THE SUTURES, ANCHOR PULLED OUT. NO ANCHOR WAS USED IN THE SAME INSERTION HOLE, HOLE WAS TOO BIG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTPRINT PEEK 4.5 M FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5 MBI SMITH & NEPHEW ENDOSCOPY 72202901 50344753

    Patients

    Seq Age Sex Outcome Treatment
    1