BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3201036 · Received July 2, 2013

    Report

    Report Number
    0008010177-2013-00143
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 COURSE AS WELL AS THE FRACTURED SURFACE SHOWED THE APPEARANCE OF A FORCED RUPTURE RESULTING FROM VERY HIGH TORSIONAL AND BENDING FORCES. ADDITIONALLY, PRESSURE MARK WAS SEEN AT THE SLOT AREA OF THE BLADE, POINTING TO THE OCCURRENCE OF HIGH BENDING FORCES. BASED ON INVESTIGATION RESULTS, 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 INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. IT WAS BROKEN DURING SURGERY AND THE BROKEN PART WAS NOT LEFT INSIDE THE PATIENT'S BODY.

    Description of Event or Problem · 1

    DURING INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. IT WAS BROKEN DURING SURGERY AND THE BROKEN PART WAS NOT LEFT INSIDE THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303301 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING EXEMPT LXH STRYKER OSTEOSYNTHESIS-FREIBURG AB02

    Patients

    Seq Age Sex Outcome Treatment
    1