BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINDLE ASSEMBLY FOR TRIAL SPACER HANDLE

    MDR report key: 3070788 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10722
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. 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. ADDITIONAL INFORMATION: THE LOT NUMBER PROVIDED CANNOT BE VERIFIED AS A VALID SYNTHES OR SUPPLIER LOT NUMBER, HENCE, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. (B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 TRIAL SPACER HANDLE SPINDLE ASSEMBLY WAS RETURNED FOR A MANUFACTURING EVALUATION WITH APPROXIMATELY 3.8MM OF THREAD REMAINING ON THE TIP. APPROXIMATELY 2.5MM OF MATERIAL HAD BEEN REMOVED FROM THE TIP. THE SHAFT AND HANDLE HAD SCRATCHES INDICATING USE. THE MEASURABLE DIMENSIONS AND MATERIAL PROPERTIES WERE MEASURED WITHIN PRINT SPECIFICATION. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT BECAUSE THE MISSING PORTION OF THE PRODUCT MAKES PHYSICAL DIMENSIONAL VERIFICATION IMPOSSIBLE. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS ALSO PERFORMED. THIS FAILURE HAS NOT BEEN REPLICATED WITH THE LATEST SPINDLE ASSEMBLY BY PRODUCT DEVELOPMENT WHILE FOLLOWING PROPER TECHNIQUE DESCRIBED IN THE TECHNIQUE GUIDE AND TRAINING. WHILE THIS INSTRUMENT WAS CONSTRUCTED WITH THE UPDATED, LESS BRITTLE MATERIAL, PER THE PREVIOUSLY IMPLEMENTED DESIGN CHANGE DURING THE RESOLUTION OF AN INTERNAL CORRECTIVE ACTION, THERE IS STILL A POTENTIAL FOR THIS FAILURE TO OCCUR IF PROPER TECHNIQUE IS NOT FOLLOWED AND LARGE DISPLACEMENT MANIPULATIONS ARE APPLIED WHILE THE INSTRUMENT IS IN A LOOSENED STATE. THE IMPLEMENTATION OF THIS NEW MATERIAL, AS WELL AS THE UPDATES TO THE TECHNIQUE AND ADDITIONAL CONSULTANT TRAINING, HAS LOWERED THE OCCURRENCE RATE OF THIS FAILURE MODE SINCE THE INTERNAL CORRECTIVE ACTION RESOLUTION. AS THIS FAILURE MODE IS KNOWN TO OCCUR IF THE TECHNIQUE IS NOT FOLLOWED AND THE DEVICE IS USED IN A LOOSENED STATE, IT IS INDETERMINATE WHETHER THE COMPLAINT IS A RESULT OF THE DEVICE DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE AT L5-S1, THE TIP OF THE SPINDLE ASSEMBLY FOR TRIAL SPACER HANDLE BROKE OFF INSIDE THE TRIAL SPACER, LEAVING THE TRIAL IN THE DISC SPACE. THE SURGEON WAS ABLE TO RETRIEVE THE TRIAL SPACER. ANOTHER ALIF SET WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 1 OF 2 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172984 SPINDLE ASSEMBLY FOR TRIAL SPACER HANDLE LXH SYNTHES MONUMENT 78540

    Patients

    Seq Age Sex Outcome Treatment
    1