BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FW BPB #5 SUTR,BLU W/NDL

    MDR report key: 5384760 · Received January 22, 2016

    Report

    Report Number
    1220246-2016-00001
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    December 11, 2015
    Report Date
    January 4, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K122374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (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 DISCARDED BY THE FACILITY, 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 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 POSSIBLE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS 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. DEVICE WAS DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ADVERSE REACTION TO A FIBERWIRE DEVICE FOR A MID-SUBSTANCE ACHILLES RUPTURE. FOLLOW-UP INVESTIGATION: A #2 FIBERWIRE WAS USED FOR AN ACHILLES TENDON REPAIR. IT WAS REPORTED THAT TWO MONTHS POST-OP, THE PATIENT HAD A REACTION TO THE DEVICE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015. THE FIBERWIRE WAS REMOVED AND A SUTURE AND A NON-ARTHREX GRAFT WAS USED TO REVISE THE ORIGINAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44662 FW BPB #5 SUTR,BLU W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other AR-7200, FW,BPB #2 SUTR, BLU, LOT UNKNOWN