BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESH CUTTER

    MDR report key: 2921745 · Received January 18, 2013

    Report

    Report Number
    8030965-2013-00170
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THAT A FACILITY IN (B)(6) HAD THE FOLLOWING EVENT: THE TIP OF THE MESH CUTTER WAS NOTED AS BROKEN. THE CIRCUMSTANCES ARE UNKNOWN AND THE BROKEN PIECE WAS NOT INCLUDED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28064 MESH CUTTER MESH CUTTER HXZ SYNTHES GMBH T933855

    Patients

    Seq Age Sex Outcome Treatment
    1