BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX ANCHOR LONG SHAFT

    MDR report key: 1052313 · Received May 21, 2008

    Report

    Report Number
    1825034-2008-00154
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BIOMET SPORTS MEDICINE/BIOMET
    Product Code
    HWC
    PMA / PMN Number
    K040475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. THE FOLLOWING USER FACILITY INFO IS AVAILABLE. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED, EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE IN 2008, THE GUIDE WIRE BROKE OFF INSIDE THE ANCHOR AND WAS REMOVED FROM THE PT. A DELAY OF 10-15 MINS WAS EXPERIENCED WITH NO PT INJURY REPORTED. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMAX ANCHOR LONG SHAFT HWC BIOMET SPORTS MEDICINE/BIOMET NA 142750

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK