BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-PUSHLOCK 4.5MM X 18.5MM

    MDR report key: 1051786 · Received May 22, 2008

    Report

    Report Number
    1220246-2008-00097
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    ARTHREX INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL AND THE CUSTOMER'S COMPLAINT COULD NOT BE VERIFIED. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE CAUSE OF THE COMPLAINANT'S EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EYELET TIP OF THE DEVICE BROKE (SPLIT) ON INSERTION DURING A ROTATOR CUFF REPAIR. THE ANCHOR WAS REMOVED BUT THE EYELET WAS LEFT IN THE PT'S BONE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER DEVICE. NO FURTHER PT INFO IS AVAILABLE AND NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-PUSHLOCK 4.5MM X 18.5MM BIO-ABSORBABLE IMPLANT MAI ARTHREX INC. NA 162622

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other