BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-TRANSFIX, 5 MM X 50 MM

    MDR report key: 1371615 · Received February 6, 2009

    Report

    Report Number
    1220246-2009-00003
    Event Type
    Other
    Date Received
    February 6, 2009
    Date of Event
    September 16, 2008
    Report Date
    January 13, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K062466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIO-TRANSFIX PIN WAS RECEIVED BROKEN IN HALF APPROXIMATELY AT THE MIDPOINT OF THE OVERALL LENGTH. WHEN JOINED AT THE POINT OF SEPARATION, THE IMPLANT APPEARS TO BE BOWED; THE COMPLAINT WAS CONFIRMED. EVALUATION REVEALED HEAVY SURFACE DAMAGE TO THE OD OF THE IMPLANT INFLICTED AS A RESULT OF EXTRACTION. THE BREAK OCCURRED SLIGHTLY DISTAL TO THE FURTHEST POINT OF THREAD PENETRATION INTO THE IMPLANT. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. IT IS UNKNOWN WHETHER THE BREAKAGE OCCURRED DURING THE INITIAL IMPLANTATION, POST-OP, OR DURING REVISION SURGERY. 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 CONFIRM TO THE SAME PATH AS THE GRAFT PASSING WIRE. CONSTANT AND/OR DYNAMIC LOAD PLACED ON THE IMPLANT AFTER EIGHT MONTHS IN VIVO COULD HAVE CAUSED THE PLASTIC DEFORMATION (BOW/BEND) IN THIS CASE. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND FROM DEVICE EVALUATION. THIS IS THE SECOND COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 8 MONTHS POST-OP, A SECOND SURGERY WAS PERFORMED BECAUSE OF PATIENT COMPLAINTS; THE PATIENT'S INITIAL HAMSTRING ACL REPAIR FAILED. DURING THE REVISION SURGERY IT WAS DISCOVERED THAT THE IMPLANT WAS BROKEN INTO TWO PIECES. THE REPORTER WAS UNSURE IF THE IMPLANT BROKE DURING EXPLANATION OR IF THE ACL REPAIR FAILED BECAUSE THE IMPLANT BROKE IN VIVO. THE TRANSFIX WAS RETRIEVED/REMOVED FROM THE PATIENT. NO FURTHER DETAILS REGARDING THE OUTCOME OF THE REVISION SURGERY WERE PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO MULTIPLE FOLLOW-UP COMMUNICATION REQUESTS. 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, 5 MM X 50 MM MAI ARTHREX, INC. NA 123371

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other INFORMATION REQUESTED BUT NOT PROVIDED.