BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, BIO-CORKSCREW

    MDR report key: 5995142 · Received October 3, 2016

    Report

    Report Number
    1220246-2016-00433
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    December 6, 2011
    Report Date
    September 2, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867023352
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. THIS IS THE FIRST OF TWO SUBMISSIONS FROM THE SAME PATIENT EVENT. THE OTHER IS 1220246-2016-00434 (CC95836 LINE 170389). 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. NO DEVICE MALFUNCTION IDENTIFIED. AT THIS TIME, IT CANNOT BE DETERMINED IF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO ARTHREX. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS A REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF 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. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. 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. PART REMAINS IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT THAT SHE UNDERWENT A RIGHT ROTATOR CUFF REPAIR ON (B)(6) 2011. PATIENT WAS INQUIRING THE MATERIAL COMPOSITION OF HER IMPLANTS. SPECIFIC IMPLANT PART NUMBERS WERE NOT KNOWN. PATIENT WAS DIRECTED TO CONTACT THE PROCEDURE FACILITY TO REQUEST THE IMPLANT LOG TO OBTAIN SPECIFIC PART NUMBERS. ADDITIONAL INFORMATION OBTAINED 09/6/16: PATIENT PROVIDED PART NUMBERS OF THE IMPLANTS FOR WHICH SHE NEEDS MATERIAL COMPOSITION: AR-1927BCF (CC95836 LINE 170266) AND AR-2324BCM (CC95836 LINE 170389). MATERIAL COMPOSITION HAS BEEN PROVIDED TO THE PATIENT. ADDITIONAL INFORMATION OBTAINED 9/8/16: PATIENT STATES SHE HAS BEEN HAVING A REACTION IN THE HEALING PROCESS SUCH THAT THE INCISION AREA HAS NEVER HEALED AND HAS STAYED RED WITH INFLAMMATION AND AT TIMES ITCHY. IN (B)(6) 2013 PATIENT WENT TO ER FOR DIFFICULTY BREATHING. SINCE THAT TIME PATIENT HAS DEALT WITH A MULTITUDE OF ISSUES AND HAS BEEN SEEN BY MANY SPECIALIST AT SEVERAL FACILITIES. PATIENT STATES RETENTION OF TOO MUCH CARBON DIOXIDE, FAST PACED BREATHING PATTERN, BODY IN STATE OF DEHYDRATION DESPITE ADEQUATE WATER INTAKE AND USING SALT, ELECTROLYTES AND HYALURONIC ACID, FATIGUE AND INCREASED ISSUE BREATHING DUE TO GASPING AND GLOBUS WITH PHYSICAL ACTIVITY, FLUCTUATING BALANCE AND INABILITY TO DRIVE. PATIENT STATES THAT IT APPEARS THAT WHATEVER IS CAUSING HER ISSUE HAS ALSO ACTIVATED TICK BORNE RELATED ILLNESS OF BARTONELLA. PATIENT HAS RECEIVED VARIOUS TREATMENTS OVER THE YEARS BUT ISSUES HAVE NOT DISSIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644489 SUTURE ANCHOR, BIO-CORKSCREW FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 458906 00888867023352

    Patients

    Seq Age Sex Outcome Treatment
    1 Other