BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER SHAFT T25-LONG STRAIGHT TIP/6MM HXC

    MDR report key: 3070094 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10925
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 2, 2012
    Report Date
    July 2, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE DEVICE WAS RECEIVED, HOWEVER, NO EVALUATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED. EACH OF THE FAILURE MODES OF THE DRIVERS (TWISTING, BREAKAGE, DEFORMATION OF THE MATERIAL, AND SEPARATION OF THE SILICONE HANDLE FROM THE DRIVER SHAFT) INDICATE EXCESSIVE FORCE BEING USED DURING THE ATTEMPTED REMOVAL OF THE LOCKING CAP. THE COMPLAINT DESCRIPTION SPECIFICALLY STATES THAT THE DRIVER ISSUES OCCURRED DURING REMOVAL OF THE LOCKING CAP, WHICH HAD BEEN FINAL TIGHTENED. IN ADDITION, THE SURGEON DID NOT USE THE TORQUE-LIMITING HANDLE. THE MATRIX TECHNIQUE DESCRIBES THE NEED TO USE A TORQUE LIMITING HANDLE WHEN REMOVING ALREADY LOCKED LOCKING CAPS. THE COMPLAINT IS DEEMED INVALID AS THE TORQUE LIMITING HANDLE WAS NOT USED DURING THE REMOVAL OF THE LOCKING CAPS.

    Additional Manufacturer Narrative · 1

    L3-L4 TREATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TLIF PROCEDURE, L2-3, 3-4, 4-5, AFTER THE FINAL TIGHTENING OF THE LOCKING CAP THE SURGEON DECIDED TO TRY AND REMOVE THE LOCKING CAP IN ORDER TO REPOSITION OR REMOVE A SCREW DUE TO THE LENGTH OF THE SCREW. IN ATTEMPTING TO DO SO, THE SCREW DRIVER SHAFT BROKE, THE TIP OF ONE HANDLE BROKE AND THE OTHER HANDLE IS NOW LOOSE. THE SC NOTED THAT THE TORQUE LIMITING TOOL WAS NOT USED. ALL OF THE PIECES WERE RETRIEVED AND THE SURGERY WAS COMPLETED, LEAVING THE LOCKING CAP TIGHTENED AND INTACT AND THE SCREW IN PLACE. THE SC REPORTS THAT APPROXIMATELY 5 MINUTES MAY HAVE BEEN ADDED TO THE CASE DUE TO THE COMPLAINT. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    L3-L4 TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171879 SCREWDRIVER SHAFT T25-LONG STRAIGHT TIP/6MM HXC HXX SYNTHES GMBH 7778138

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR