BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE LIGHT 10/PK

    MDR report key: 3099733 · Received May 8, 2013

    Report

    Report Number
    0008010177-2013-00017
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 16, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    FSQ
    PMA / PMN Number
    K961122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE VISUAL INVESTIGATION SHOWED THAT PARTS OF THE TRANSPARENT SURROUNDING WERE BROKEN. THE BREAKAGE OF THE TRANSPARENT SURROUNDING WAS CAUSED BY TOO STRONG FORCES IN TERMS OF A BENDING OVERLOAD DURING USE OF THE DEVICE. THERE CORROSION FOUND ON THE WORKING PART OF THE DEVICE AS WELL, WHICH CLEARLY INDICATES THAT THE DEVICE WAS USED. BASED ON THE PERFORMED INVESTIGATION, NO INDICATIONS WERE FOUND FOR ANY SYSTEMATIC, DESIGN OR MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KNIFELIGHT BROKE AT THE TIP DURING A CASE. THE PIECE WAS RECOVERED AND THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KNIFELIGHT BROKE AT THE TIP DURING A CASE. THE PIECE WAS RECOVERED AND THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201556 KNIFE LIGHT 10/PK INSTRUMENT FSQ STRYKER OSTEOSYNTHESIS-FREIBURG 11043FE2

    Patients

    Seq Age Sex Outcome Treatment
    1