BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 SET SCREW NEW VERSION

    MDR report key: 3851253 · Received March 26, 2014

    Report

    Report Number
    3005673311-2014-00026
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    December 11, 2013
    Report Date
    March 5, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWP
    PMA / PMN Number
    K032219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MANUFACTURING SITE EVALUATION: TWO INVOLVED POLYAXIAL SCREWS SW773T (LOT 51567528) AND SW773T (LOT 51441524) WERE RECEIVED FOR INVESTIGATION. THE SCREWS WERE INSPECTED MICROSCOPICALLY. THE THREAD OF ONE POLYAXIAL SCREW (LOT 51567528) SHOWS VISIBLE DAMAGE ON BOTH SIDES. THE MOST LIKELY CAUSE FOR THIS ERROR PATTERN IS, THAT THE SCREW WAS CROSS THREADED. ANOTHER INDICATION FOR A CROSS-THREADED SET SCREW IS THE USE OF A FW251R S4 ELEMENT HANDLED SET SCREW INSERTER. THE FW251R IS NOT ADEQUATE FOR THIS SYSTEM AND RESULTS IN AN INCORRECT SETTING OF THE SCREW. THE FW177R S4C OCCIPUT LATERAL HOLE GUIDE IS THE CORRECT INSTRUMENT FOR THIS SYSTEM AND ENSURES A TILT FREE FIXATION OF THE SET SCREW. THIS FAILURE IS PROBABLY A USER RELATED ERROR. THE MANUFACTURING DOCUMENTATION HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS FOR A MATERIAL OR MANUFACTURING DEFECT.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE SCREWS WERE PLACED ON BOTH SIDES OF TWO LUMBER VERTEBRAS (4 SCREWS ALTOGETHER). SET SCREWS WERE PLACED AND THE SURGEON STARTED TIGHTENING THE SET SCREWS TWICE DURING PROCEDURE. FIRST ATTEMPT: THE SURGEON PLACED THE SET SCREW USING S4 ELEMENT SET SCREW STARTER. HOWEVER, THE SET SCREW WOULD NOT BE FIXED IN THE SCREW HEAD. AS A RESULT, THE SURGEON REPLACED BOTH THE SET SCREW AND THE PEDICLE SCREW. SECOND ATTEMPT: THE SURGEON ATTEMPTED TO TIGHTEN THE SET SCREW USING COUNTER-TORQUE HANDLE AND TORQUE WRENCH. AT THE TIME OF FINAL TIGHTENING, THE SET SCREW WOULD NOT BE FIXED. HE HAD DIFFICULTY CONNECTING THE TORQUE WRENCH INTO THE SET SCREW. NO SOFT TISSUE INTERVENED BETWEEN THE SET SCREW AND THE TORQUE WRENCH. FINALLY, BOTH THE SET SCREW AND THE PEDICLE SCREWS WERE REPLACED. SURGICAL DELAY GREATER THAN 15 MINUTES. DEVICE 1 OF 4; SEE 3005673311-2014-00024, 00025, 00027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176809 S4 SET SCREW NEW VERSION KWP AESCULAP AG & CO. KG SW773T 515667528

    Patients

    Seq Age Sex Outcome Treatment
    1