BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIV O FIXABLE X-RAY TRANSP. BLADE SZ.M

    MDR report key: 2565539 · Received April 27, 2012

    Report

    Report Number
    3005673311-2012-00020
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    January 20, 2012
    Report Date
    April 5, 2012
    Manufacturer
    AESCULAP AG & CO. KG.
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US DIVISION WAS NOTIFIED (B)(4) 2012; RECEIVED TRANSLATION (B)(4) 2012. EVAL IS NOT COMPLETE; STILL UNDER INVESTIGATION. CAUSE FOR FRACTURES IS UNCLEAR. MACROSCOPICALLY, IT IS POSSIBLE TO DETECT THE CRACK INITIATION/PROPAGATION. IT IS NOT OBVIOUS WHETHER THE SUBSURFACE DEFECTS WERE PRESENT PRIOR TO THE FRACTURE OR CAUSED UPON CRACK PROPAGATION. SURFACE DEFECTS ARE HARDLY VISIBLE. BEING SENT FOR EXTERNAL ANALYSIS.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DEVICE 1. THE ACTIV-O RETRACTOR SYSTEM WAS USED FOR THE OPENING IN A 2ND SURGERY OF HYDROLIFT AND MACS II. AFTER 20-30 MINUTES RETRACTION, THE BLADES BROKEN UNEXPECTEDLY ONE AFTER ANOTHER, ALTHOUGH NO MANIPULATION HAD TAKEN PLACE AT THAT MOMENT. TWO TIMES (B)(4) (DEVICE 1) AND 1X (B)(4) (DEVICE 2) WERE INVOLVED IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIV O FIXABLE X-RAY TRANSP. BLADE SZ.M GFA AESCULAP AG & CO. KG. BV863P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other