BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET ADAPTER T2 SCN

    MDR report key: 5505496 · Received March 16, 2016

    Report

    Report Number
    0009610622-2016-00129
    Event Type
    Malfunction
    Date Received
    March 16, 2016
    Date of Event
    February 18, 2016
    Report Date
    February 18, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THIS INVESTIGATION REVEALED THE TARGET ADAPTER T2 SCN TO BE AS PRIMARY PRODUCT. THE NAIL HOLDING SCREW T2 SCN AND THE NAIL ADAPTER T2 SCN WHICH WERE NOT RETURNED FOR EVALUATION ARE REGARDED AS ASSOCIATED PRODUCTS. DISCREPANCIES IN MANUFACTURING WERE NOT FOUND. THE PRODUCT APPEARED TO BE BRAND NEW. IT WAS MANUFACTURED IN NOVEMBER 2015. PRE-OPERATIVE-CHECK PERFORMED REVEALED THE TARGET ADAPTER RETURNED BEING FULLY FUNCTIONAL WITH RETURNED SCN NAIL. THE SUBJECT OF THE REPORTED EVENT COULD NOT BE REPRODUCED. THE REPORTED EVENT IS DUE TO A SUBOPTIMAL SURGERY PROCEDURE MOST LIKELY THE THUMB SCREW WAS NOT TIGHTENED WHEN THE CORRECT POSITIONS 1 ¿ 4 WERE VISIBLE IN THE LOCKING WINDOW ¿ THUS THE TARGETING ARM WILL NOT STAY IN SECURED POSITION FOR DRILLING. THE REPORTED EVENT WAS NOT CAUSED BY ANY DEFICIENCY IN THE DEVICES. ALTHOUGH A REAL ROOT CAUSE COULD NOT BE DETERMINED THE ALLEGED EVENT IS MOST LIKELY CAUSED DUE TO A SUBOPTIMAL INTRA-OPERATIVE PROCEDURE.

    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 T2 SCN LONG SURGERY, THE SURGEON PERFORMED CALIBRATION COMBINING THE TARGET ARM AND THE NAIL. TO USE A CONDYLAR SCREW, THE SURGEON USED 5MM OF DRILL. HOWEVER, THE DRILL BIT CONTACTED THE SCREW HOLE OF NAIL OF NO.1 AND NO. 4. THEREFORE THE SURGEON CHANGED THE NAIL TO ANOTHER SIZE NAIL. AND THE SURGEON PERFORMED CALIBRATION COMBINING THE TARGET ARM AND THE NAIL AGAIN. HOWEVER, THE DRILL BIT CONTACTED THE SCREW HOLE OF NAIL OF NO.1, 2, 3 AND NO.4. THEREFORE THE SURGEON USED 4.2MM OF DRILL AND FIXED THE NAIL BY 5MM SCREW.

    Description of Event or Problem · 1

    DURING T2 SCN LONG SURGERY, THE SURGEON PERFORMED CALIBRATION COMBINING THE TARGET ARM AND THE NAIL. TO USE A CONDYLAR SCREW, THE SURGEON USED 5MM OF DRILL. HOWEVER, THE DRILL BIT CONTACTED THE SCREW HOLE OF NAIL OF NO.1 AND NO4. THEREFORE THE SURGEON CHANGED THE NAIL TO ANOTHER SIZE NAIL. AND THE SURGEON PERFORMED CALIBRATION COMBINING THE TARGET ARM AND THE NAIL AGAIN. HOWEVER, THE DRILL BIT CONTACTED THE SCREW HOLE OF NAIL OF NO.1, 2, 3 AND NO.4. THEREFORE THE SURGEON USED 4.2MM OF DRILL AND FIXED THE NAIL BY 5MM SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161326 TARGET ADAPTER T2 SCN ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KME908133

    Patients

    Seq Age Sex Outcome Treatment
    1 Other