BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLTHREAD LACTOSORB ANCHOR

    MDR report key: 1033145 · Received April 22, 2008

    Report

    Report Number
    1825034-2008-00109
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 28, 2008
    Manufacturer
    BIOMET SPORTS MEDICINE/BIOMET
    Product Code
    JDR
    PMA / PMN Number
    K061389
    Removal / Correction Number
    NA
    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 AVAIL. EVALUATION OF RETURNED DEVICE FOUND EVIDENCE THE TIP FRACTURED IN BENDING OVERLOAD. MOREOVER, THERE IS EVIDENCE OF CRAZING ON THE ANCHOR BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT SURGICAL PROCEDURE IN 2008, UTILIZING AN ALLTHREAD LACTOSORB ANCHOR. WHEN IMPLANT WAS OPENED, IT WAS NOTICED THAT THERE WAS NO TIP ON THE END OF THE ANCHOR. ANOTHER ANCHOR OF THE SAME PART/LOT COMBINATION WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLTHREAD LACTOSORB ANCHOR JDR BIOMET SPORTS MEDICINE/BIOMET NA 051490

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other