BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOMPOSITE PUSHLOCK, 3.5MM X 19.5MM

    MDR report key: 1935182 · Received December 22, 2010

    Report

    Report Number
    1220246-2010-00255
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED, BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT KNOWN. TYPICALLY THIS TYPE OF EVENT IS CAUSED BY PREPARING A PILOT HOLE THAT IS TOO SMALL, INSERTING THE IMPLANT AT AN ANGLE THAT IS NOT CO-AXIAL TO THE PILOT HOLE OR PRYING/LEVERAGING THE DRIVER WHILE THE IMPLANT IS STILL LOADED. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION, THE ANCHOR BROKE. ONE HALF OF THE ANCHOR STAYED FIXED IN THE PATIENT AND THE OTHER HALF HAD TO BE RETRIEVED FROM THE JOINT IN SMALL PARTS. PROCEDURE: STABILITY REPAIR OF SHOULDER (LABRUM FIXATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCOMPOSITE PUSHLOCK, 3.5MM X 19.5MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other