BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5

    MDR report key: 8660373 · Received May 31, 2019

    Report

    Report Number
    1219602-2019-00650
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    March 21, 2019
    Report Date
    June 18, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    UDI-DI
    03596010650535
    PMA / PMN Number
    K093897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 72202902 FOOTPRINT ULTRA PK 5.5MM SUTURE ANCHOR DEVICE RETURNED. THE COMPLAINT STATED: ¿THE NAIL WAS PULLED OUT OF THE HANDLE, THE CORE OF THE NEEDLE WAS BENT AND IN ORDER TO STRAIGHTEN THE NEEDLE CORE, IT BROKE.¿ THE ANCHOR WAS RETURNED. SUTURE WAS NOT RETURNED. THE SUTURE THREADER WAS RETURNED. THE TORQUE LIMITER IS FUNCTIONAL. AUDIBLE CLICK IS HEARD UPON ROTATION. THE INNER SHAFT WAS SNAPPED FROM FORCE. THE ANCHOR WAS FRACTURED FROM LATERAL TORQUE WHERE THE INSERTER AND ANCHOR SEAT TOGETHER. THE CONDITIONS ARE CONSISTENT WITH LOSS OF AXIAL ALIGNMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT KNEE ANTERIOR CRUCIATE LIGAMENT FRACTURE, AFTER PRE-DRILLING AT THE PROXIMAL END OF THE TIBIA, KNOCK INTO THE TENDON WITH A HAMMER TO FIX THE ANCHOR TIMING, THE NAIL WAS PULLED OUT OF THE HANDLE, THE CORE OF THE NEEDLE WAS BENT AND IN ORDER TO STRAIGHTEN THE NEEDLE CORE, IT BROKE. THEN TRY TO HIT THE NAIL DIRECTLY WITH THE HANDLE, AND THE NAIL BURSTS FROM THE MIDDLE. THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451363 FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5 FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 50667720 03596010650535

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR