BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY CHISEL 6MM

    MDR report key: 3082699 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-02070
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THIS DEVICE IS INTENDED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RECEIVED FOR A MANUFACTURING EVALUATION. THE TRIAL IMPLANT WAS STUCK ONTO THE CHISEL AND WAS VERY DIFFICULT TO DISENGAGE. THE CHISEL WAS NOT USED THE WAY IT WAS INTENDED AS IT WAS NOT ENTERED PROPERLY INTO THE GUIDEWAYS. THE CHISEL WAS FORCED IN AT AN ANGLE CAUSING ONE OF THE TIPS TO WEDGE OUT. THE CHISEL CORRESPONDED TO THE DRAWINGS AND PROCESSES AT THE TIME OF MANUFACTURE. ALL MATING DIMENSIONS WITH THE CHISEL WERE INSPECTED AND FOUND TO BE CONFORMING. NO IRREGULARITIES WERE FOUND DURING THE MEASURING. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS ALSO PERFORMED. THE CHISEL WAS RECEIVED JAMMED OFF AXIS ON THE TRIAL IMPLANT. THE BLADE OF THE CHISEL WAS DEFORMED AROUND THE STOP OF THE TRIAL IMPLANT. THE CHISEL IS CLEARLY OFF-AXIS AS THE SHAFT OF THE TRIAL IS NOT ALIGNED NOR INSERTED INTO THE CHISEL. THE SURGEON MAY HAVE NOT ALIGNED THE CHISEL ALONG THE TRIAL IMPLANT PRIOR TO IMPACTION. THIS MAY HAVE LED TO THE JAMMING OF THE CHISEL AROUND THE STOP OF THE TRIAL IMPLANT. THE DRAWINGS WERE REVIEWED FOR BOTH PARTS AND THERE IS ADEQUATE CLEARANCE FOR THE DEVICES TO FUNCTION AS INTENDED. THE MATERIALS WERE ALSO REVIEWED AND ARE ADEQUATE FOR THE DEVICE INTENDED USE. AS THERE IS NOT ENOUGH INFORMATION AS TO HOW THE CHISEL/TRIAL WAS USED DURING THE SURGERY, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A DESIGN PERSPECTIVE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    BASED ON ABOVE OBSERVATION OF THE COMPONENTS INVOLVED IN THIS COMPLAINT, THE SURGEON CLEARLY MIS-ALIGNED THE CHISEL ON THE TRIAL NOT FOLLOWING THE TECHNIQUE OUTLINED IN THE PRODISC-C SURGICAL TECHNIQUE GUIDE J7501-E. EVEN THOUGH THE COMPLAINT DESCRIPTION STATES THAT THERE WAS NO DELAY TO THE PROCEDURE AND NO REPORTED ADVERSE EFFECT TO THE PATIENT IN THIS CASE, THIS EVENT COULD BE CLASSIFIED AS FORESEEABLE MISUSE THAT COULD POTENTIALLY LEAD TO A SLIGHT DELAY IN SURGERY IF IT WOULD HAPPEN AGAIN IN ANOTHER CASE. THIS FORESEEABLE MISUSE IS CURRENTLY NOT COVERED IN THE RISK ANALYSIS FOR THE CHISELS AND AS SUCH THE RISK ANALYSIS WILL HAVE TO BE UPDATED TO INCLUDE THIS RISK. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, DURING A PRODISC-C PROCEDURE AT C6-C7, THE CHISEL STUCK TO THE TRIAL SPACER. THE SURGEON USED THE CHISEL AND TRIAL SPACER FROM ANOTHER SET TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE AND NO REPORTED ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183908 SECONDARY CHISEL 6MM FZO SYNTHES GMBH 5675091

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR