BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-MEDIC WIRE CUTTER FLUSH FRONT/SIDE

    MDR report key: 1762841 · Received June 28, 2010

    Report

    Report Number
    3005236665-2010-00003
    Event Type
    Malfunction
    Date Received
    June 28, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    K-MEDIC EUROPE GMBH
    Product Code
    HXZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MANUFACTURER BUT INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE TOP OF THE PIN CUTTER FELL OFF CUTTING A ROD DURING HIP SURGERY. NO PATIENT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-MEDIC WIRE CUTTER FLUSH FRONT/SIDE WIRE CUTTER HXZ K-MEDIC EUROPE GMBH NA 656

    Patients

    Seq Age Sex Outcome Treatment
    1