BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE ANCHOR

    MDR report key: 1063699 · Received June 20, 2008

    Report

    Report Number
    1221934-2008-00321
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 6, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT BEING RETURNED TO MITEK, BUT THE LOT NUMBER WAS PROVIDED SO A LOT REVIEW WILL BE CONDUCTED. NO FURTHER ACTION IS WARRANTED AT THIS TIME. HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT WHEN THE SURGEON REMOVED THE DRILL GUIDE, THE ANCHOR SHATTERED. THE SURGEON WAS ABLE TO REMOVE ALL OF THE PIECES AND THEN USED A COMPETITORS ANCHOR TO COMPLETE THE CASE WITHOUT FURTHER INCIDENT. THERE WERE NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUPINE ANCHOR FULLY ABSORBABLE ANCHOR MAI DEPUY MITEK 210711 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK