BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P3-PRONG BEND-PLIERS F/PI 1.5/2

    MDR report key: 2566430 · Received May 2, 2012

    Report

    Report Number
    8030965-2012-00198
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    March 9, 2012
    Report Date
    April 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE SURGEON WAS BENDING PLATES FOR A PT WITH A CHEEK BONE FRACTURE. SEVERAL PLATES WERE BENT AND THE HANDLE OF THE 3-PRONG BEND-PLIERS SEEMED TO BE STUCK. AS A RESULT THE PLATE WAS SCRATCHED AND FAILED THE BENDING. SURGEON TRIED TO BEND ONE MORE PLATE AND THE BENDING FAILED. THE LAST PLATE WAS OUT OF POSITION. NO FURTHER INFO WAS AVAILABLE. THIS IS ONE OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P3-PRONG BEND-PLIERS F/PI 1.5/2 3 PRONG BEND-PLIERS HTC SYNTHES GMBH 3211941

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PLATE.| PLIERS.| PLIERS| PLATE