BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE HOLDER CEV500T5 DIA 5MM TUNGSTEN

    MDR report key: 3337832 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00401
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S.
    Product Code
    GCJ
    PMA / PMN Number
    K080257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 2: CEV500T5 (LOT: 120301) - MANUFACTURING DATE: 03/2012. (B)(6). EVALUATION OF THESE DEVICES INDICATED THAT THE BOTTOM OF THE JAW WAS BROKEN AND TRACES OF CORROSION HAVE BEEN NOTED ON THE FRACTURE ZONE. A SIGNIFICANT PRESENCE OF ORGANIC AND MINERAL RESIDUES WERE ALSO NOTED. NO MANUFACTURIGN NOR MATERIAL DEFECTS WERE NOTED. THE DEVICES WERE MOST LIKELY DROPPED OR SUFFERED FROM IMPACT THAT WEAKENED THE DEVICES AND LED TO THE BREAKAGE OBSERVED DURNG USE. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC'S MXI FACILITY IN (B)(4). THIS REVIEW WAS CONDUCTED IN RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. MXI CAPA (B)(4) WAS OPENED TO ADDRESS THESE ISSUES. MEDTRONIC'S INTERNAL REFERENCE #: NA. (B)(4).

    Description of Event or Problem · 1

    TWO DEVICES (CEV500T5) WERE RETURNED FOR REPAIR TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427475 NEEDLE HOLDER CEV500T5 DIA 5MM TUNGSTEN GCJ MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV500T5 120301

    Patients

    Seq Age Sex Outcome Treatment
    1