BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 18MM

    MDR report key: 3040258 · Received April 8, 2013

    Report

    Report Number
    8030965-2013-10719
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    April 30, 2012
    Report Date
    April 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K071667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT DEVELOPMENT EVALUATION STATED THAT THERE WERE MINOR SURFACE SCRAPES IN THE VIOLET ANODIZE ON THE CROWNS OF THE THREADS AND ON THE INSIDE OF THE 4 TABS ON THE HEAD. THE INTERNAL THREADS ARE INTACT AND A NEW INNER SHAFT FOR EXTRACTION SCREWDRIVER WAS SUCCESSFULLY INSERTED AND SECURED INTO THE SCREW. THE RETURNED SCREW IS UNDAMAGED AND FUNCTIONS AS INTENDED. A NEW INNER SHAFT FOR EXTRACTION SCREWDRIVER (03.613.004) WAS INSERTED AND FULLY SEATED INTO THE SCREW AND TORQUE COULD BE APPLIED TO SIMULATE REMOVAL OF THE SCREW. THE TECHNIQUE GUIDE PROVIDES A CAUTION THAT IF THE INNER SHAFT KNOB IS NOT FULLY TIGHTENED, BREAKAGE OF THE DRIVER MAY OCCUR. THIS COMPLAINT IS FOR BREAKAGE OF THE TIP OF THE INNER SHAFT AND THERE DOES NOT APPEAR TO BE ANY ISSUE WITH THE RETURNED SCREW. THE RETURNED PART FUNCTIONS AS INTENDED AND THEREFORE THE COMPLAINT FOR THIS PART IS INVALID.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ACF C5-C6, C6-C7 PROCEDURE, THE SURGEON WAS REMOVING ONE OF THE SCREWS TO REPOSITION IT. THE THREADS ON THE INNER SHAFT OF THE DRIVER BROKE OFF INTO THE SCREW HEAD. THE SCREW WAS REMOVED WITH THE TIP OF THE INNER SHAFT REMAINING IN THE HEAD OF THE SCREW. THERE WERE NO FRAGMENTS TO RETRIEVE. THE SURGEON INSERTED ANOTHER SCREW WITH A DIFFERENT DRIVER AND COMPLETED THE PROCEDURE. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142557 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 18MM KWQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1