BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL RONGEURS, 9", SLIGHT CURVE, 8MM BITE

    MDR report key: 694614 · Received March 30, 2006

    Report

    Report Number
    2430952-2006-00012
    Event Type
    Malfunction
    Date Received
    March 30, 2006
    Report Date
    March 30, 2006
    Manufacturer
    KAPP GMBH
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS TRYING TO CUT BONE AND THE INSTRUMENT CRACKED IN HALF. NO PATIENT INJURY WAS REPORTED. THE REPORTED PRODUCT CODE WAS 230-240. THE MANUFACTURER CONFIRMED THE CORRECT PRODUCT CODE SHOULD BE 230-261, AFTER CONDUCTING THE INVESTIGATION. THE MANUFACTURER ALSO REPORTED, THAT THEY COULD NOT DETERMINE THE EXACT CAUSE FOR THE JAW BREAKAGE AND THAT THE PRODUCTION RECORD RECORD AND HARDNESS TESTING OF THE RETURNED INSTRUMENT INDICATE COMPLIANCE TO THE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL RONGEURS, 9", SLIGHT CURVE, 8MM BITE JARIT ORTHOPEDIC SURGERY INSTRMENTS HTX KAPP GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *