BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-TRANSFIX, 5MM X 40MM, LONG

    MDR report key: 1272868 · Received December 22, 2008

    Report

    Report Number
    1220246-2008-00252
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    November 24, 2008
    Report Date
    November 24, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    MNU
    PMA / PMN Number
    K011172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RELEASED BY THE FACILITY RISK MANAGEMENT, 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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS GRAFT WIRE THAT IS NOT INSERTED STRAIGHT. IF, DURING INSERTION, THE GRAFT WIRE IS PASSED THROUGH THE GRAFT AND IT IS NOT STRAIGHT, THE IMPLANT WILL TEND TO CONFORM TO THE SAME PATH AS THE GRAFT PASSING WIRE. CONSTANT AND/OR DYNAMIC LOAD PLACED ON THE IMPLANT AFTER TIME IN VIVO CAN LEAD TO PLASTIC DEFORMATION AND BREAKAGE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 6 MONTHS POST-OP, AN X-RAY REVEALED THE IMPLANT HAD BROKEN. THE PATIENT HAD ALREADY HEALED FROM THE ACL PROCEDURE SO THE IMPLANT WAS SUBSEQUENTLY REMOVED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR IN FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TRANSFIX, 5MM X 40MM, LONG MNU ARTHREX, INC. NA 141541

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention INFORMATION REQUESTED BUT NOT PROVIDED.