BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2502520 · Received March 16, 2012

    Report

    Report Number
    2502520
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 16, 2012
    Manufacturer
    JARIT
    Product Code
    KNF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE LAST USE, AFTER USING THE INSTRUMENT FOR THE ENTIRE CASE, THE TEAM PULLED OUT THE INSTRUMENT AND NOTED THE RING PIECE FELL OFF. AFTER CLOSER INSPECTION, IT WAS NOTED A SCREW WAS MISSING. X-RAY DONE ON THE PATIENT AND THE SCREW WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FORCEPS KNF JARIT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR