BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5

    MDR report key: 4964763 · Received August 4, 2015

    Report

    Report Number
    1219602-2015-00683
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    January 6, 2015
    Report Date
    January 6, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K113274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) K093897. NO PRODUCT RETURNED FOR EVALUATION. METHOD - PRODUCT NOT RETURNED FOR THE EVALUATION. EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS AND QUALITY RECORDS ASSOCIATED WITH THIS MANUFACTURED LOT CONFIRMED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN FILED AND THAT NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT DURING MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    PATIENT WHO HAD A PROCEDURE IN (B)(6) HAD AN MAGNETIC RESONANCE IMAGING MRI POST OPERATIVE, WHICH SHOWED THE CUFF IS NOT REPAIRED / HEALED. AN FOOTPRINT ANCHOR FROM LOT 50506999 WAS ALSO USED. ACCORDING TO THE SALES REP, OTHER SHOULDER PRODUCTS WERE USED IN THE CASE, SUCH AS TRUEPASS AND ULTRABRAID SUTURE. IT WAS REPORTED THAT OTHER SHOULDER PRODUCTS WERE USED IN THE CASE, SUCH AS TRUEPASS AND ULTRABRAID SUTURE. THE PATIENT DECIDED NOT TO HAVE A SECOND PROCEDURE. THE SURGEON IS NOT SURE WHAT THE REASON IS FOR THE FAILURE. THE PATIENT STILL REFUSES TO HAVE A FOLLOW UP PROCEDURE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508157 FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5 FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 50477832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other