BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2822260 · Received May 29, 2012

    Report

    Report Number
    1220246-2012-00105
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    May 3, 2012
    Report Date
    December 13, 2007
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K041553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE MEDICAL RECORDS FROM THE PROCEDURE SHOWS NO ARTHREX IMPLANTS BEING USED, ONLY THE COMPETITORS. THE DEVICE, BRAIDED FIBERWIRE, WAS USED TO PREPARE THE GRAFT PRIOR TO SURGERY AND WAS NOT RETURNED FOR EVALUATION 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. 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 AN ACL PROCEDURE WAS PERFORMED ON (B)(6) 2007. ACL FAILED, CAUSING ADDITIONAL PAIN TO PATIENT. PATIENT IS CLAIMING INJURY TO HER BODY AND TO HER NERVOUS SYSTEM. IT WAS STATED BY THE REPORTING SOURCE THAT ARTHREX'S FIBERWIRE WAS USED TO PREPARE THE GRAFT PRIOR TO SURGERY. MEDICAL RECORDS RECEIVED. THE "IMPLANT/EXTRAORDINARY SUPPLY LOG" THAT WAS PROVIDED DOES NOT SHOW ANY ARTHREX IMPLANTS ONLY SMITH&NEPHEW, COMMED, DEPUY/MITEK.

    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. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other