BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01778

    MDR report key: 3030040 · Received April 2, 2013

    Report

    Report Number
    2520274-2013-01778
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT ONE OF THE EMPLOYEES WAS INJURED WHILE HANDLING A 1.25MM KIRSCHNER WIRE WITH TROCAR POINT 150MM IN ITS ORIGINAL PACKAGING TUBE. THE PACKAGING TUBE IS A PLASTIC TELESCOPING CONTAINER WHICH REPORTEDLY DOES NOT HAVE STOPS IN THE TUBE TO PREVENT IT FROM CLOSING SHORTER THAN THE LENGTH OF THE KIRSCHNER WIRE. THE CUSTOMER STATED THAT THE SHARP POINT OF THE WIRE PIERCED THE PLASTIC TUBE WITH EASE, AND THE EMPLOYEE RECEIVED A PUNCTURE INJURY WHEN CLOSING THE TUBE. REPORTEDLY THE EMPLOYEE IS STILL UNABLE TO WORK DUE TO INJURY. THIS REPORT IS FOR AN UNKNOWN 1.25MM KIRSCHNER WIRE WITH TROCAR POINT 150MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134876 LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention