BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIF SIZER HANDLE

    MDR report key: 3049794 · Received April 10, 2013

    Report

    Report Number
    1719045-2013-10605
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    GDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR SYNTHES LOT NUMBERS 4720635, 4724898, AND 4767000 REVEALED THE DEVICE WAS MANUFACTURED BY ENVISION MANUFACTURING INCORPORATION. ONE NONCONFORMANCE WAS FOUND FOR LOT 4720635. RELEVANCE TO THE COMPLAINT CONDITION COULD NOT BE DETERMINED. LOT 4724898 WAS INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET. ONE NONCONFORMANCE WAS FOUND FOR LOT 4767000; HOWEVER, THE NONCONFORMANCE WAS NOT RELEVANT TO THE COMPLAINT CONDITION. THE SUPPLIER CERTIFICATES OF COMPLIANCE INDICATED THAT THE PARTS WERE MANUFACTURED TO THE CORRECT MATERIAL REQUIREMENTS, AND MET THE HARDNESS AND REQUIRED SPECIFICATIONS. BASED ON THE DHR EVALUATION PERFORMED, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. THE DEVICE WAS RETURNED FOR A PRODUCT DEVELOPMENT EVALUATION. THE THREADED TIP WAS BROKEN OFF THE SPINDLE AT THE POINT THAT THE TIP EXITS THE SHAFT. THE THREADED TIP WAS ALSO RETURNED AND THERE WERE CRACKS ON ONE SIDE OF THE TIP IN THE ROOTS OF THE TWO THREADS CLOSEST TO THE FRACTURE SURFACE. THE FRACTURE SURFACE OF THE TIP WAS CANTED SLIGHTLY AWAY FROM THE CRACKS. THE FRACTURE SURFACE ON BOTH THE TIP AND THE END OF THE SPINDLE WAS FLAT ACROSS APPROXIMATELY HALF THE PART AND THEN THERE WAS A NOTICEABLE ROUGHER PROFILE OVER THE REMAINING SURFACE WITH A LARGE PEAK ON THE SPINDLE AND VALLEY ON THE TIP. THERE WERE NICKS AND DINGS ON THE EDGES OF THE TABS ON THE END OF THE SHAFT. THE RETURNED DEVICE WAS MANUFACTURED IN MARCH OF 2004 AND WAS OVER 8 YEARS OLD. THE FRACTURE SURFACES ON BOTH THE END OF THE SPINDLE AND THE THREADED TIP WERE CONSISTENT WITH A PART THAT WAS SUBJECTED TO A SIGNIFICANT SIDE LOAD WHICH BENT AND ULTIMATELY BROKE THE THREADED TIP OFF THE SPINDLE. ADDITIONALLY, THERE WERE CRACKS IN THE ROOTS OF THE LAST 2 THREADS ON THE TIP FRAGMENT ON ONLY ONE SIDE, AND THE FRACTURE SURFACE WAS BENT SLIGHTLY AWAY FROM THEM, WHICH IS ALSO CONSISTENT WITH THAT FAILURE MODE. THE HANDLE IS USED TO HOLD THE SIZERS IN ORDER TO DETERMINE THE IMPLANT SIZE FOR THE PREPARED DISC SPACE. IT IS NOT INTENDED TO BE SUBJECTED TO SIGNIFICANT LOADING SINCE THE DISTRACTOR IN THE SYSTEM IS INTENDED TO HOLD THE SPACING WHILE DETERMINING THE SIZE. THEREFORE, IT APPEARS THAT THE DEVICE WAS USED INCORRECTLY WHICH RESULTED IN THE COMPLAINT CONDITION. THE ROOT CAUSE IS MISUSE AND THIS COMPLAINT IS DEEMED INVALID FROM A DESIGN STANDPOINT. 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT L3-S1, THE SURGEON WAS USING THE HANDLE WITH DILATOR TO OPEN DISC SPACE WHEN THE THREADED PORTION OF THE HANDLE BROKE OFF IN THE DILATOR. THE SURGEON USED ANOTHER HANDLE AND DILATOR TO COMPLETE THE PROCEDURE. TEN MINUTES WERE ADDED TO THE PROCEDURE TO RETRIEVE THE FIRST DILATOR FROM THE DISC SPACE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153039 ALIF SIZER HANDLE GDZ SYNTHES MONUMENT 8012

    Patients

    Seq Age Sex Outcome Treatment
    1