BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-FASTAK SUTURE ANCHOR WITH #2 FIBERWIRE

    MDR report key: 1031780 · Received April 18, 2008

    Report

    Report Number
    1220246-2008-00059
    Event Type
    Other
    Date Received
    April 18, 2008
    Report Date
    February 14, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL REVEALED THE SUTURE LOOP WITH THE FIBERWIRE HAD COME OFF BECAUSE THE IMPLANT HAD BROKEN AT THE HEX PORTION. THIS PORTION, RETURNED WITH THE DRIVER, HAS A WHITE AND BRITTLE APPEARANCE. DUE TO THE CONDITION OF THE IMPLANT, DIMENSIONAL INSPECTION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. A DEFINITIVE CONCLUSION FOR THIS EVENT COULD NOT BE MADE FROM THE INFO AVAILABLE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AFTER INSERTING THE ANCHOR AND WHILE REMOVING THE DRIVER FROM THE PT, THE SUTURE EYELET AND THE FIBERWIRE CAME OFF AND THE ENTIRE ANCHOR REMAINED IN THE PT. MDR DETERMINATION FOR THIS EVENT WAS RE-EVALUATED ON (B) (6) 2008, AFTER RECEIVING AND EVALUATING THE DEVICE. A PARTIAL ANCHOR RATHER THAN AN ENTIRE ANCHOR WAS DETERMINED TO HAVE BEEN LEFT INSIDE THE PT. NO FURTHER PT INFO IS AVAILABLE AND 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-FASTAK SUTURE ANCHOR WITH #2 FIBERWIRE BIO-ABSORBABLE SUTURE ANCHOR MAI ARTHREX, INC. NA 89913

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other