BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3012417 · Received March 20, 2013

    Report

    Report Number
    0008010177-2013-00044
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 HAD APPEARANCE OF A DUCTILE 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

    DURING ASNIS MICRO SURGERY, THE SCREWDRIVER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116288 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1