BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERWIRE, BRAIDED PB #2 SUTURE, BLUE W/NEEDLE

    MDR report key: 2832948 · Received November 15, 2012

    Report

    Report Number
    1220246-2012-00218
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K041553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, WEIGHT) WERE REQUESTED, BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION, BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. IT IS NOTED IN THE EVENT THAT THE IMPLANTS USED IN THE PROCEDURE WERE NOT ARTHREX'S. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS AN ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF ADVERSE EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POSSIBLE REACTION. PT ORIGINALLY HAD ROTATOR CUFF SURGERY ON (B)(6) 2011 (OPEN PROCEDURE). THE SURGICAL REPORT STATES #2 FIBERWIRE WAS USED. ON (B)(6) 2011, THE STAPLES WERE REMOVED AND THE SURGICAL SITE WAS REOPENED AND THE ENTIRE REPAIR HAD SEPARATED WITH THE FIBERWIRE IN A MASS. THE COMPETITOR'S ANCHORS ARE STILL INTACT. ALL PATHOLOGY REPORTS WERE NEGATIVE. THE AREA WAS DRAINED AND FLUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBERWIRE, BRAIDED PB #2 SUTURE, BLUE W/NEEDLE SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other