BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE LIGHT 10/PK

    MDR report key: 3141037 · Received June 3, 2013

    Report

    Report Number
    0008010177-2013-00107
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    FSQ
    PMA / PMN Number
    K961122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THERE WERE DEFORMATION AND CRACKS IN THE TRANSPARENT SURROUNDING INSTEAD OF BREAKAGE. THE VISUAL INVESTIGATION SHOWED THAT THE DEFORMATION AND CRACKS OF THE TRANSPARENT SURROUNDING WAS CAUSED BY TOO STRONG FORCES IN TERMS OF A BENDING OVERLOAD DURING USE OF THE DEVICE. FURTHERMORE, IT WAS POSSIBLE TO TURN ON THE LIGHT. 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 DURING CARPAL TUNNEL PROCEDURE WHILE USING THE KNIFELIGHT, (B)(4) A PIECE BROKE OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CARPAL TUNNEL PROCEDURE WHILE USING THE KNIFELIGHT, REF # (B)(4) A PIECE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244549 KNIFE LIGHT 10/PK SURGICAL INSTRUMENT FSQ STRYKER OSTEOSYNTHESIS-FREIBURG 12138FE2

    Patients

    Seq Age Sex Outcome Treatment
    1