BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X300MM X 12

    MDR report key: 2974541 · Received December 12, 2012

    Report

    Report Number
    9610622-2012-00565
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    STRYKER TRAUMA GMBH
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, SURGEON WAS DOING A PROCEDURE ON PATIENT¿S LEFT SIDE AND WENT TO USE A LONG GAMMA NAIL. WHEN THE NURSE CIRCULATOR OPENED THE PACKAGE ON PART NUMBER: (B)(4), THEY NOTICED A LONG BLONDE OR GRAY HAIR IN THE PACKAGE AND SET THE PART ASIDE. PART WAS NOT IMPLANTED, PART WILL BE RETURNED. SURGEON DECIDED TO GO WITH A 380 NAIL AND COMPLETED THE SURGERY WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X300MM X 12 IMPLANT HSB STRYKER TRAUMA GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other