BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FW,BPB #2 SUTR,BLU W/NDL

    MDR report key: 8321475 · Received February 8, 2019

    Report

    Report Number
    1220246-2019-00888
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    October 31, 2014
    Report Date
    February 8, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867041264
    PMA / PMN Number
    K122374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. A POSSIBLE CAUSE OF THIS TYPE OF EVENT MAY BE A REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED OR USED DURING THE IMPLANT PROCEDURE. PATIENT SENSITIVITY TO MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. ARTHREX¿S DIRECTIONS FOR USE PACKAGED WITH THE FIBERWIRE® SUTURE STATES THAT SILICONE SENSITIVITY, THOUGH VERY RARE, HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PATIENT HAD SUFFERED A SHOULDER INJURY IN 2011 WHILE WORKING. ON (B)(6) 2013 SHE UNDERWENT A SHOULDER PROCEDURE DURING WHICH AN ARTHREX AR-7209 LOT 10667 (#2 FIBERSTICK, #2 FIBERWIRE) AND AN AR-7200 LOT UNKNOWN (FIBERWIRE BRAIDED PB #2 SUTURE, BLUE W/NEEDLE) WERE UTILIZED. FOLLOWING THE (B)(6) 2013 SURGERY THE PATIENT BEGAN TO EXPERIENCE REACTION TYPE SYMPTOMS WHICH THE PATIENT REPORTED TO ARTHREX ON (B)(6) 2014 ((B)(4) MEDWATCH 1220246-2014-00200). AT THAT TIME THE PATIENT REPORTED THAT SHE HAD BEEN HAVING HIVES WITH A POSSIBLE REACTION TO THE FIBERWIRE. THE PATIENT ALSO REPORTED THAT SHE HAD BEEN SEEN BY A DERMATOLOGIST BUT THE OUTCOME HAD BEEN INCONCLUSIVE AT THAT TIME. NO FURTHER INFORMATION WAS PROVIDED TO ARTHREX. ON JANUARY 9, 2019, ARTHREX RECEIVED A CD FROM THE PATIENT CONTAINING VOLUMINOUS MEDICAL RECORDS. THE MEDICAL RECORDS NOTE THE PATIENT CONTINUED TO HAVE ISSUES FOLLOWING HER (B)(6) 2013 RIGHT SHOULDER SURGERY INCLUDING ANAPHYLACTIC SHOCK EPISODES, ANGLOEDEMA AND URTICARIA. THE PATIENT WAS SEEN BY MULTIPLE MEDICAL PROFESSIONALS TO DETERMINE WHAT WAS CAUSING HER FREQUENT EPISODES OF ANAPHYLAXIS. IT WAS IDENTIFIED VIA A PATCH TESTING OF THE FIBERWIRE BY A DERMATOLOGIST THAT THE ARTHREX FIBERWIRE SUTURE USED IN HER SHOULDER MAY BE CAUSING THESE REACTIONS. ALTHOUGH THE RESULTS WERE INCONCLUSIVE, A REMOVAL SURGERY WAS RECOMMENDED. ON (B)(6) 2014, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE FIBERWIRE SUTURE. ACCORDING TO THE PATIENT¿S MEDICAL RECORDS, FOLLOWING THE REMOVAL SURGERY, THE ANAPHYLACTIC SHOCK CONDITION HAS SUBSIDED AND NO NEW EPISODES HAVE OCCURRED SINCE THE REMOVAL. THE RECORDS ALSO INDICATE THAT ¿THINGS THAT MAKE THIS CONDITION WORSE ARE CERTAIN THINGS SHE TOUCHES SUCH AS SILICON.¿ ALTHOUGH THE PATIENT IS NO LONGER SUFFERING REACTION SYMPTOMS SHE IS STILL HAVING ISSUES WITH HER SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112566 FW,BPB #2 SUTR,BLU W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. FW,BPB #2 SUTR,BLU W/NDL UNK 00888867041264

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other