BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS OMNI WITH ATTACHED CORD

    MDR report key: 2631035 · Received June 21, 2012

    Report

    Report Number
    2183680-2012-00033
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    March 26, 2012
    Report Date
    May 24, 2012
    Manufacturer
    GYRUS MEDICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K081766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. DURING OUR INVESTIGATION, WE FOUND THAT THE HUB WAS FRACTURED. THE DEVICE WAS RETURNED WITH A FRACTURED HUB, THE FRACTURE SITE WAS UNDER THE HEAT SHRINK. THE HEAT SHRINK COVERS THE SHAFT AND THE BACK OR PROXIMAL END OF THE JAWS. UPON REMOVAL OF THE HEAT SHRINK, THERE WERE NO PIECES OF THE CERAMIC HUB OBSERVED ON THE INSIDE OF THE HEAT SHRINK. THE HUB FRACTURED JUST BEHIND THE CTR PIVOT RIVET AT THE THIN TO THICK TRANSITION AREA OF THE PART. WHEN THE TWO PARTS OF THE HUB WERE PLACED BACK TOGETHER, ALL PARTS ARE ACCOUNTED FOR. FAILURES SUCH AS THESE CAN BE ASSOCIATED WITH EXCESSIVE FORCE OR ROTATIONAL FORCES BEING APPLIED TO THE DISTAL OR WORKING END OF THE DEVICE. WE WILL MONITOR THE COMPLAINT DATABASE FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUSACMI THAT DURING A SURGICAL PROCEDURE, THE TIP OF TWO OMNI BROKE PROXIMAL TO THE JAW DURING SURGERY. NO PT HARM WAS REPORTED. (SEE MEDWATCH #2183680-2012-00039 FOR THE SECOND DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS OMNI WITH ATTACHED CORD PKS OMNI GEI GYRUS MEDICAL INC 970010PC 384308KD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK