BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 18MM

    MDR report key: 3070371 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10929
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    K030866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    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. (B)(4). PLACEHOLDER.

    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 DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND TWO FLANGES WERE COMPLETELY MISSING. THE TWO OTHER FLANGES WERE PARTIALLY BROKEN AND STRONGLY DEFORMED. THE EXACT CAUSE OF THE BREAKAGE OF THE TWO FLANGES COULD NOT BE DETERMINED. HOWEVER, THE THREAD FLANKS WERE FLATTENED, INDICATING THAT EXCESSIVE CONTACT WITH THE PLATE BY AN IMPROPER INSERTION ANGLE COULD HAVE CAUSED THE BREAKAGE. THE BROKEN TIP OF THE EXTRACTION SCREW WAS STILL IN THE THREAD AND COULD NOT BE REMOVED. THE COMPLETE HEAD OF THE SCREW WAS STRONGLY DAMAGED, LIKELY CAUSED BY THE EXTRACTION WITH PLIERS AS MENTIONED IN THE DESCRIPTION. THESE DAMAGES MADE A DETERMINATION OF THE DIMENSIONS IMPOSSIBLE. THEREFORE, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS ALSO PERFORMED. THE DRIVER HAS A RELATIVELY SMALL CROSS SECTIONAL AREA, WHICH IS REQUIRED TO ENGAGE THE HEAD OF THE SCREW. DUE TO THE CONICAL SHAPE OF THE INSTRUMENT, THE VARYING CROSS SECTION CAN BE SUSCEPTIBLE TO BREAKAGE IF NOT FULLY ENGAGED IN THE SCREW. THE CROSS SECTIONAL SHEAR AREA WILL INCREASE AS THE SCREW HEAD IS FURTHER ENGAGED. THERE IS A POSSIBILITY THAT THE SURGICAL TECHNIQUE OR PATIENT ANATOMY WAS SUCH THAT THE INSTRUMENT WAS NOT PERFECTLY ON AXIS WITH THE SCREW HEAD. IT CANNOT BE COMPLETELY DETERMINED WHAT THE CAUSE OF THE INCIDENT WAS. THERE IS A POSSIBILITY THAT THE SCREW WAS NOT FULLY ENGAGED OR THE DRIVER WAS LOADED WITH A SLIGHT BENDING MOMENT. IN BOTH SCENARIOS, THE STRESS WOULD BE GREATER THAN TYPICALLY ANTICIPATED ON THE INSTRUMENT AND COULD LEAD TO BREAKAGE. THIS COMPLAINT IS INDETERMINATE FROM A DESIGN STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CERVICAL SPINE LOCKING PLATE PROCEDURE OF C5-C7, THE SURGEON INSERTED THE PLATE AND ONE SCREW WITH NO PROBLEM. AS HE WAS SEATING THE SECOND SCREW INTO THE PLATE, THE FLANGES BROKE OFF. THE SURGEON TRIED BACKING OUT THE SCREW WITH A SCREWDRIVER, BUT THE SCREW WOULD NOT COME OUT. THE SURGEON THEN USED THE CONICAL EXTRACTION SCREW TO EXTRACT THE SCREW, BUT THE TIP OF THE CONICAL EXTRACTION SCREW BROKE OFF INTO THE SCREW. THE SURGEON WAS ABLE TO USE PLIERS TO BREAK OFF THE OTHER REMAINING FLANGES AND BURR DOWN INSIDE THE SCREW TO PULL THE PLATE OFF. THE SURGEON THEN PULLED THE PLATE OFF OVER THE FIRST SCREW THAT WAS IMPLANTED IN PATIENT. HE WAS ABLE TO USE VICE GRIPS TO REMOVE THE FIRST SCREW. THE SURGEON SELECTED A NEW PLATE AND SCREWS TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. ALL BROKEN PIECES WERE RETRIEVED WITH NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 2 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171146 4.5MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 18MM KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1