BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-CORKSCREW SUTURE ANCHOR

    MDR report key: 822551 · Received February 21, 2007

    Report

    Report Number
    1220246-2007-00021
    Event Type
    Injury
    Date Received
    February 21, 2007
    Date of Event
    May 18, 2005
    Report Date
    February 19, 2007
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY COULD NOT BE REVIEWED AND MANUFACTURING DATE NOT DETERMINED WITHOUT THE PART/LOT NUMBER. THE ACTUAL CAUSE OF THIS EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE. BIO-CORKSCREW SUTURE ANCHORS ARE INTENDED FOR FIXATION OF SUTURE TO BONE IN SHOULDER, KNEE, HAND, FOOT/ANKLE, AND OTHER REPAIRS UNDER K003227 AND APPROVED FOR RELEASE BY FDA AS OF 01/08/2001. THE OFFICE OF THE POSSIBLE SURGEON INVOLVED IN THIS EVENT HAS BEEN CONTACTED FOR DETAILS ON THE EVENT. A FOLLOW UP REPORT MAY BE SUBMITTED IF ADDITIONAL PERTINENT INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS EVENT WAS FIRST REPORTED TO ARTHREX VIA COPY OF THE CONSUMER VOLUNTARY REPORT SUBMITTED TO FDA UNDER MW1036435. THIS REPORT IS BEING MADE IN RESPONSE TO THIS NOTIFICATION. REPORTER STATES THE PT HAD SUSTAINED A SLIGHT STRAIN IN SHOULDER AND NEEDED REMOVAL OF A SMALL AMOUNT OF FLUID IN SHOULDER. PER REPORTER, SURGEON STATED THERE WAS A CYST THAT NEEDED REMOVAL. SURGEON USED BIO CORKSCREW PROCDUCT(S) TO REPAIR PATIENT SHOULDER IN 2003. PATIENT RETURNED WITH SEVERE PRESISTANT PAIN POST OPERATIVELY. ACCORDING TO THE REPORT, THE 2005 MRI SHOWED ONE OF THE SUTURE ANCHORS WAS SEEN HANGING LOOSE WITHIN SHOULDER. MRI ALSO SHOWED A SLAP LESION. REPORTER SEEMS TO BELIEVE THIS DEVICE WAS NOT SUITABLE FOR THE REPAIR PERFORMED IN THE PT. THE ACTUAL PART AND LOT NUMBER(S) INVOLVED ARE UNKNOWN. THE PART LISTED IS FOR REPORTING PURPOSES ONLY. THE OFFICE OF THE POSSIBLE SURGEON INVOLVED HAS BEEN CONTACTED FOR ADDITIONAL INFO. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CORKSCREW SUTURE ANCHOR BIO-ABSORBABLE SUTURE ANCHOR MAI ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention