BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARLING RONGEUR

    MDR report key: 931155 · Received October 12, 2007

    Report

    Report Number
    931155
    Event Type
    Injury
    Date Received
    October 12, 2007
    Date of Event
    August 8, 2007
    Report Date
    October 9, 2007
    Product Code
    JYR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY A PIECE (FOOTPLATE) OF A RONGEUR BROKE OFF AND RETRIEVED FROM THE SURGICAL SITE. NO ADD'L SURGERY WAS REQUIRED, AND THE PATIENT RECOVERED WITHOUT COMPLICATIONS. THE RONGEUR WAS DELIVERED TO REPROCESSING WHO NOTIFIED THE MANUFACTURER'S REP OF THE EVENT AND GAVE HIM THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPARLING RONGEUR BONE NIPPERS JYR NL4071-082

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention