BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 3072255 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10846
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    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 MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MAUNFACTURING EVALUATION, VISUAL INSPECTION REPORT STATED THAT THE DEVICE WAS RETURNED WITH THE INNER SHAFTS TIP IS BROKEN WHERE THE THREAD STARTS. THE TIP OF THE DRIVER SHAFT APPEARS WORN. THE MEASURABLE DIMENSIONS ARE WITHIN PRINT SPECIFICATION. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT BECAUSE THE DAMAGED PORTION OF THE PRODUCT MAKES PHYSICAL DIMENSIONAL VERIFICATION IMPOSSIBLE. THE PRODUCT DEVELOPMENT EVALUATION REPORT STATED THERE IS NOTHING TO INDICATE ANYTHING IS WRONG WITH THE PART. THE CAUSE WILL MOST LIKELY BE FROM IMPROPER USER TECHNIQUE. BASED ON THE COMPLAINTS WE HAVE RECEIVED IN THE PAST, THE SHAFT WAS POSSIBLY NOT FULLY THREAD INTO THE SCREW AND AN EXCESSIVE SIDE LOAD WAS APPLIED. IT HAS BEEN DETERMINED THAT THE LOAD NECESSARY TO BREAK THAT PART OF THE INSTRUMENT WILL MOST LIKELY BE SEEN IN THE PRODUCTS MISUSE. A CAPA WAS PUT IN PLACE IN JUNE OF 2006 TO INCREASE THE STRENGTH AND DUCTILITY OF THE SHAFT TO HELP PREVENT ISSUES RESULTING FROM EXCESSIVE SIDE LOADS OCCURRING FROM THIS MISUSE. TRAINING AND TECHNIQUE GUIDES EMPHASIZE THE PROPER TECHNIQUE. THERE IS STILL A POSSIBILITY TO REMOVE ALL SCREWS AND THE PLATE AFTER A SHAFT IS BROKEN INSIDE ONE OF THE SCREWS. MANUFACTURING FOUND THAT THIS PART IS AN OLDER PART, MADE FROM THE MATERIAL BEFORE THE CAPA WAS PUT IN PLACE. THE MATERIAL MAKES IT A VALID COMPLAINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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)

    Description of Event or Problem · 1

    PATIENT STATUS POST ACDF (ANTERIOR CERVICAL DECOMPRESSION FUSION) C4-5, C5-6 IMPLANTATION ON AN UNKNOWN DATE HAD AN X-RAY ON AN UNKNOWN DATE THAT SHOWED A NON-UNION AND ADJACENT LEVEL DISEASE. THE PLATE AND SIX SCREWS WERE INTACT AND NOT BROKEN. DURING THE PROCESS OF REMOVAL OF THE PLATE AND SCREWS A PIECE OF THE EXTRACTION SCREWDRIVER BROKE OFF. THE SURGEON VACUUMED UP THE PART AND COMPLETED REMOVING THE PLATE AND SCREWS WITHOUT INCIDENT. PATIENT WAS REVISED TO TWO PLATES AND SCREWS. EVENT #8 OF 8 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ACDF (ANTERIOR CERVICAL DECOMPRESSION FUSION) WAS PERFORMED AT C5-6, C6-7. THERE WAS A NON-UNION OF C6-7. THE PLATE WAS REMOVED AT C5-6,C6-7. THE PATIENT WAS REVISED TO FUSION AT C3-4, C4-5, AND C6-7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173723 EXTRACTION SCREWDRIVER HXX SYNTHES MONUMENT 557359K05

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR