BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6874829 · Received September 18, 2017

    Report

    Report Number
    0008010177-2017-00234
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Date of Event
    August 21, 2017
    Report Date
    November 14, 2017
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE TIPS OF TWO ¿2.0MM ASNIS MICRO, CANNULATED SCREWDRIVERS, 2.0MM, AO COUPLING¿ BROKE DURING A SURGERY, COULD BE CONFIRMED, SINCE BOTH DEVICES WERE RETURNED FOR EVALUATION AND THEY MATCH THE REPORTED FAILURE MODE. THE 1ST REPORTED ¿2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING¿ WAS RECEIVED BROKEN AT THE TIP. SOME BROKEN PIECES OF THE TIP WERE ALSO RECEIVED. THE VISUAL INSPECTION REVEALED THAT THE SCREWDRIVER LOOKS USED, THE BLUE COLOR-CODING RINGS ARE FADED, AND THE FLUTES ARE SLIGHTLY TWISTED. THE BREAKAGE SURFACE APPEARS TO BE DULL WITH A FIBROUS FINISHING AND SOME CRACKS AROUND, WHILE THE EDGE OF THE REMAINING TIP IS SLIGHTLY DEFORMED WITH CRACKS AND SIGNS OF RUST. THESE PATTERNS ARE CONSISTENT WITH OVER-TORQUEING OF THE INSTRUMENT. THE SCREWDRIVER WAS MOST LIKELY TWISTED UNDER HIGH LOADS AND EVENTUALLY BROKE. SUCH POWER, IN COMBINATION WITH HARD BONE, AND EVEN VIOLENT MOVES, COULD DEFINITELY DEFORM THE SCREWDRIVER AND LEAD TO SUCH A BREAKAGE. SINCE THE INSPECTION REVEALED SIGNS OF WEAR WITH A CIRCULAR MOVEMENT, IT IS EVIDENT THAT THE BREAKAGE OCCURRED WHILE ROTATING THE SCREWDRIVER. THE DEVICE WAS REPORTED TO BE PART OF A LOANER KIT, AND IS CONSIDERED A MULTIPLE-USE INSTRUMENT. THIS MEANS THAT IT EXPERIENCES A LOT OF USAGE, STERILIZATION PROCESSES AND TRANSPORTATION THROUGHOUT THE YEARS, AND ALL THESE PROCEDURES CAN DEFINITELY AFFECT ITS INTEGRITY. AS PER IFU (90-01972): ''ENSURE THAT YOU ARE FAMILIAR WITH THE RECOMMENDED USES, COMPATIBILITY AND CORRECT HANDLING OF THE INSTRUMENT! ONLY USE AN INSTRUMENT FOR ITS INTENDED PURPOSE. ALWAYS TREAT THE INSTRUMENT CAREFULLY TO AVOID SURFACE DAMAGE OR ALTERATIONS TO THE INSTRUMENT GEOMETRY. THE DESIGN OF THE INSTRUMENT MUST NOT BE MODIFIED IN ANY WAY. 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." AS PER CLEANING AND STERILIZATION GUIDE (L24002000): ''THE GUIDANCE CONCENTRATIONS AND TIMES FOR DEVICE IMMERSION IN THE CLEANING SOLUTIONS AND/OR DISINFECTANTS GIVEN BY THE DETERGENT MANUFACTURERS SHALL BE OBSERVED. IF THESE CONCENTRATIONS AND TIMES ARE EXCEEDED SIGNIFICANTLY, DISCOLORATION OR CORROSION COULD OCCUR WITH SOME MATERIALS. STRYKER TRAUMA & EXTREMITIES TYPICALLY DOES NOT SPECIFY THE MAXIMUM NUMBER OF USES APPROPRIATE FOR RE-USABLE MEDICAL DEVICES. THE USEFUL LIFE OF THESE DEVICES DEPENDS ON MANY FACTORS INCLUDING THE METHOD AND DURATION OF EACH USE, AND THE HANDLING BETWEEN USES.¿ IF THE DEVICE HAS NOT BEEN USED CAREFULLY AND UNDER APPROPRIATE CLEANING CONDITIONS, IT IS QUITE POSSIBLE THAT ITS INTEGRITY HAS BEEN COMPROMISED, WHICH IS DEFINITELY A DEVIATION FROM THE SPECIFICATIONS. BASED ON THE INVESTIGATION, THE CASE COULD BE CLASSIFIED AS USER-RELATED DUE TO OVER-TORQUE. 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, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. THE DESIGN OF THE DEVICE HAS BEEN CHANGED IN ORDER TO IMPROVE THE STRENGTH OF THE TIP. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. IN TERMS OF GOODWILL, THE CUSTOMER WILL BE PROVIDED WITH A CREDIT NOTE.

    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

    DURING SURGERY, THE DRIVER BROKE.

    Description of Event or Problem · 1

    DURING SURGERY, THE DRIVER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652258 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. LXH STRYKER LEIBINGER FREIBURG AB11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other