BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-CORKSCREW SUTURE ANCHOR W/ TWO #2 FIBERWIRE, 5.0MM

    MDR report key: 1023854 · Received April 1, 2008

    Report

    Report Number
    1220246-2008-00052
    Event Type
    Other
    Date Received
    April 1, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 3, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED WERE NOT RETURNED AND THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/ LOT COMBINATION. THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO IMPLANTS BROKE ON INSERTION DURING A SHOULDER ARTHROSCOPY (SUBACROMIAL DECOMPRESSION/ROTATOR CUFF REPAIR). THE PROCEDURE WAS CONVERTED TO A MINI-OPEN REPAIR TO ALLOW THE SURGEON TO RE-DRILL AND INSERT ANOTHER IMPLANT. THE IMPLANTS' TIPS REMAIN IN THE PT'S BONE. NO FURTHER PT INFO IS AVAILABLE AND NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CORKSCREW SUTURE ANCHOR W/ TWO #2 FIBERWIRE, 5.0MM BIO-ABSORBABLE SUTURE ANCHOR MAI ARTHREX, INC. NA 60830

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other