BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.6CM TAPERED ATTACHEMENT, BLACK MAX

    MDR report key: 3000203 · Received February 14, 2013

    Report

    Report Number
    1045834-2013-00236
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 17, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND WAS FOUND TO HAVE WORN AND DAMAGED INTERNAL COMPONENTS. THIS IS DUE TO NORMAL USAGE AND WEAR OVER TIME. THE EVENT WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "LOOSE IN THE SHAFT" AND THERE WAS "RATTLING" INSIDE THE DEVICE. THE RATTLING WAS FOUND DURING CLEANING BY THE INSTRUMENT TECHNICIAN, PRIOR TO PATIENT USE. IT WAS UNKNOWN TO THE REPORTER WHETHER OR NOT THE DEVICE WAS USED IN SURGERY. THERE WERE NO INJURIES OR MEDIAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64932 12.6CM TAPERED ATTACHEMENT, BLACK MAX GFF THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1