BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6044980 · Received October 20, 2016

    Report

    Report Number
    0008031020-2016-00519
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 26, 2016
    Report Date
    May 19, 2017
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    LXH
    UDI-DI
    04546540534385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING WAS ALLEGED OF 'BREAKAGE DURING SURGERY' COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THE FAILURE WAS CAUSED BY THE APPLICATION OF EXCESSIVE FORCE ON THE DEVICE. THE DEVICE INSPECTION REVEALED THAT THE TIP OF THE SCREWDRIVER IS BROKEN. THE BREAKAGE SURFACE IS CONSISTENT WITH A FATIGUE BREAKAGE DUE TO THE APPLICATION OF EXCESSIVE FORCE ON THE SCREWDRIVER BLADE. NOTE, AS STATED IN THE IFU (90-01972): ALWAYS TREAT THE INSTRUMENT CAREFULLY TO AVOID SURFACE DAMAGE OR ALTERATIONS TO THE INSTRUMENT GEOMETRY. CAREFUL HANDLING AND STORAGE OF THE PRODUCT IS REQUIRED. SCRATCHING OR DAMAGE TO THE INSTRUMENTS CAN SIGNIFICANTLY REDUCE THE STRENGTH AND FATIGUE RESISTANCE OF THE PRODUCT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ASNIS MICRO 2.0 SCREW WAS USED IN THE TOE. DURING SURGERY, THE TIP OF THE DRIVER BROKE AND THE A FRAGMENT REMAINED IN THE PATIENT. THIS EVENT WAS FOUND AFTER THE SURGERY.

    Description of Event or Problem · 1

    ASNIS MICRO 2.0 SCREW WAS USED IN THE TOE. DURING SURGERY, THE TIP OF THE DRIVER BROKE AND THE A FRAGMENT REMAINED IN THE PATIENT. THIS EVENT WAS FOUND AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696335 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. LXH STRYKER LEIBINGER FREIBURG AB10 04546540534385

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other