BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES

    MDR report key: 1022546 · Received March 27, 2008

    Report

    Report Number
    1220246-2008-00050
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    February 10, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT WAS CONFIRMED. EVALUATION REVEALED THE ANCHOR PIN THAT HOLDS THE SUTURE IN PLACE HAD BROKEN LOOSE. THE ANCHOR SUTURES WERE RETURNED IN PIECES. A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED FROM THE INFO AVAILABLE. DEVICE HISTORY RECORD REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED THIS EVENT. THIS IS THE THIRD COMPLAINT OF THIS TYPE OF THIS PART/LOT COMBINATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURES CAME LOOSE DURING A ROTATOR CUFF REPAIR. THE ANCHOR WAS COMPLETELY RETRIEVED AND ANOTHER ANCHOR WAS PLACED TO COMPLETE THE REPAIR. THE SURGERY WAS DELAYED FORTY FIVE MINUTES, BUT NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED FROM THE EVENT. NO FURTHER PATIENT INFO IS AVAILABLE. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES SUTURE ANCHOR DEVICE MBI ARTHREX, INC. NA 120922

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other