BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.8 MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 4199376 · Received October 22, 2014

    Report

    Report Number
    3006524618-2014-00311
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    July 25, 2014
    Report Date
    January 26, 2016
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K133727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND BIOLOGICAL INSPECTION COULD NOT BE PERFORMED BECAUSE THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SUBJECT LOT NUMBER SHOWS THAT THE DEVICE EXPIRATION DATE IS LISTED AS MAY 2017. A REVIEW OF THE STERILITY RECORDS WAS PERFORMED AND ALL INDICATE THAT ALL ETO STERILIZATION TESTS PASSED UPON RELEASE TO DISTRIBUTION. THUS, THERE IS NO INDICATION THAT THE PATIENT'S INFECTION WOULD HAVE BEEN CONTRIBUTED BY THE DEVICE. BECAUSE THERE ARE NO INDICATIONS TO SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION, IT IS POSSIBLE THE INFECTION EXISTED IN THE PATIENT BEFORE THE SURGICAL PROCEDURE WAS PERFORMED OR WAS INDUCED BY ANOTHER SURGICAL INSTRUMENT UNASSOCIATED WITH THE DEVICE THE IFU CONTAINS WARNINGS AND PRECAUTIONS FOR APPROPRIATE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SHOULDER PROCEDURE USING A 2.8 MM Q-FIX ALL SUTURE ANCHOR, THE PATIENT RETURNED TO THE FACILITY TWO WEEKS POST PROCEDURE WITH AN INFECTED IMPLANT. THE IMPLANT WAS INSPECTED AND CLEANED BY THE SURGEON. NO ADDITIONAL DETAILS WERE PROVIDED REGARDING THE OUTCOME, HOWEVER NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674086 2.8 MM Q-FIX ALL SUTURE ANCHOR FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD MBI ARTHROCARE CORPORATION 1073039

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention