BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5

    MDR report key: 6150732 · Received December 7, 2016

    Report

    Report Number
    1219602-2016-01314
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    October 5, 2016
    Report Date
    February 22, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K093897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE CLINICAL DETAILS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE 4.5MM FOOTPRINT PK 'S PROXIMAL ANCHOR PORTION BROKE OFF FROM THE SHAFT HANDLE AFTER A FEW GENTLE TAPS INTO MEDIAL ANKLE BONE. THIS BONE HOLE WAS PREPARED, BY PRE-DRILLED WITH OUR 3.2MM GUIDE AND DRILL BIT. IT WAS FOLLOWED BY A GOLDEN AWL DILATOR UP TO THE LASER MARKING. THE ALIGNMENT WAS CLOSELY OBSERVED WHEN PUTTING IN THIS IMPLANT BUT IT STILL BROKE UNEXPECTEDLY. ALTERNATIVELY, THE SURGEON USED A 5.5 TWINFIX ULTRA PK (W NEEDLES) FOR THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800924 FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5 FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 50591779

    Patients

    Seq Age Sex Outcome Treatment
    1