BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING

    MDR report key: 3140984 · Received June 3, 2013

    Report

    Report Number
    0008010177-2013-00103
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    February 18, 2013
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION REVEALED THAT THE TIP OF THE BLADE WAS BROKEN. THE BROKEN PART WAS NOT RETURNED. FURTHERMORE, IT WAS DETERMINED THAT THE FRACTURED SURFACE OF THE BLADE SHOWED APPEARANCE OF A FORCED RUPTURE RESULTING FROM VERY HIGH TORSIONAL AND BENDING FORCES. ADDITIONALLY, PRESSURE MARKS WERE SEEN AT THE SLOT AREA OF THE BLADE POINTING TO THE OCCURRENCE OF HIGH BENDING FORCES. THE ROOT CAUSE FOR THE REPORTED EVENT CAN BE ATTRIBUTED TO A USER RELATED ISSUE. NO INDICATIONS WERE FOUND FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUE.

    Description of Event or Problem · 1

    ASNIS MICRO CANNULATED SCREWDRIVER BROKE ON THE DRIVING END OF THE DRIVER WHILE SURGEON WAS SCREWING IN THE SCREW.

    Description of Event or Problem · 1

    ASNIS MICRO CANNULATED SCREWDRIVER BROKE ON THE DRIVING END OF THE DRIVER WHILE SURGEON WAS SCREWING IN THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244434 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1