BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5

    MDR report key: 3192510 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03707
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    February 14, 2012
    Report Date
    February 27, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K022012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. THE EVALUATION REVEALED THAT THE THREE SCREWS THAT WERE SENT WERE BROKEN AT THE HEAD OF THE SCREW; THE CRANIAL PLATE DOES NOT SHOW ANY VISIBLE DAMAGE. BY THE MICROSCOPIC INVESTIGATION OF THE PLATE SOME SMALL SCRATCHES AND DAMAGES WERE SEEN ON THE SURFACE. IN THREE OF THE FOUR HOLES WE CAN DOCUMENT SMALL DEFORMATIONS, PROBABLY CAUSED WHEN INTRODUCING THE SCREW. THE DIMENSIONS OF THE THREE SCREWS HAVE BEEN COMPARED WITH THE DRAWING, TWO OF THE SCREWS WOULD CORRESPOND TO THE CRANIAL SCREW PLUSDRIVE 1.6MM, THE THIRD AND SMALLER SCREW WOULD BE A COMPACT SCREW. THE COMPACT SCREWS WERE MANUFACTURED IN PURE TITANIUM, THE CURRENT CRANIAL SCREWS PLUSDRIVE ARE MANUFACTURED OUT OF A TITANIUM ALLOY. THE THREE SCREWS SHOW DEFORMATIONS AT THE SLOT CORNER OF THE HEAD OF THE SCREW, WITH THE SMALLER SCREWS LARGER DEFORMATION WITH SCRATCHES AND LIGHT DAMAGES ON THE COMPLETE SURFACE ARE SEEABLE. BY THE FRACTOGRAPHIC INVESTIGATION WITH A RASTER ELECTRONIC MICROSCOPE (REM) A TORSION TEAR WAS SEEN FOR ALL THE SCREWS. WITH A BIGGER ENLARGEMENT HONEYCOMB BREAKS ARE SEEABLE, A CLEAR INDICATION FOR A VIOLENT DUCTILE BREAK. THE EXAMINATION OF THE ROW MATERIALS THAT WERE USED WITH A MICRO CUT DID NOT RESULT IN ANY MATERIAL ERROR. THE MICROSTRUCTURE CORRESPONDS TO THE SPECIFICATIONS OF SYNTHES. NO IRREGULARITIES (FOR EXAMPLE TRACES OF NON-METALLIC COMPONENTS) OR INDICATION OF EMBRITTLEMENT WERE FOUND. THE SCREWS FAILED BECAUSE OF A HIGH FORCE APPLIED DURING THE PLACEMENT. A COMBINATION OF FRICTION WITH THE PLATE AND A NON-FAVORABLE ANGLE BETWEEN THE PLATE AND THE BONE COVER DURING THE SCREWING IN OF THE SCREW LEAD TO HIGH RESISTANCE AND THEREFORE TO THE BREAK OF THE SCREW. THE ORIENTATION OF THE HONEYCOMBS ARE A CLEAR INDICATION OF A VIOLENT DUCTILE BREAK BY TORSION STRESS.

    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.ADDED OTHER RELEVANT HISTORY AND PREEXISTING MEDICAL CONDITIONS: CHRONIC SUBDURAL HEMATOMA, CALOTTE DEFECT RIGHT FRONTAL, SEVERE HEAD TRAUMA, HYPACUSIS. THE OPERATION CONSISTED THE RE-IMPLANTATION OF THE OWN BONE CALOTTE.(B)(4)

    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 SCREWS BROKE DURING REARRANGEMENT OF PLATE. WHILE CLOSING A CRANIAL DEFECT, LOW PROFILE NEURO SCREWS WERE USED AND INSERTED INTO THE BONE. FOR A REARRANGEMENT OF THE FIXATION PLATE THE SCREWS HAD TO BE REPLACED, AND FOUR SCREWS BROKE WHILE TAKING THEM OUT. THREE SCREWS ARE AVAILABLE FOR INVESTIGATION, 1 SCREW WAS LOST. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293572 CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5 JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR