BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER, SELF-HOLDING, EXTRA SHORT 3.5 MM

    MDR report key: 1892796 · Received November 3, 2010

    Report

    Report Number
    9610622-2010-00471
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 14, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HEAD OF THE CENTRAL STERILE SERVICES, REPORTED IN HER LETTER, THAT SHE OBSERVED A SURGERY PROCEDURE. DURING THIS PROCEDURE, SHE OBSERVED THAT THE SCREWDRIVER DOESN'T HOLD OF THE SCREWS AND DOESN'T TURN THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER, SELF-HOLDING, EXTRA SHORT 3.5 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KMW350902

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other