BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 26MM/W 32MM/H 12MM

    MDR report key: 3083750 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11168
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. PRODUCT DEVELOPMENT EVALUATION SHOWED U-JOINT AWL AND DRIVERS:THE U-JOINTS OF THE RETURNED DRIVERS ARE WORN OUT AND NO LONGER RETAIN POSITION IN ANY DIRECTION WHEN USED WITH A SYNFIX SCREW. THE U-JOINT OF THE RETURNED AWL IS WORN OUT IN ONE DIRECTION, BUT MAINTAINS POSITION IN THE OTHER DIRECTION. DRAWINGS FOR BOTH THE LOW PROFILE U-JOINT AWL (03.802.230) AND LOW PROFILE TAPERED U-JOINT DRIVER (03.802.431) CONTAIN NOTES THAT THE U-JOINT ARTICULATION SHOULD BE SMOOTH AND RETAIN SET POSITION. HOWEVER, THE RELEASED TECHNIQUE GUIDE SPECIFIES THAT THE GUIDING FORCEPS (03.802.038) PROVIDED IN THE SET SHOULD BE USED WITH BOTH THESE INSTRUMENTS AT THEIR TIME OF USE IN THE PROCEDURE. IN THE CASE OF THE AWL, THE TECHNIQUE GUIDE STATES THAT GUIDING FORCEPS SHOULD BE USED TO ENSURE DIRECTIONAL CONTROL OF THE AWL TIP AND USE THE GUIDING FORCEPS TO CONTROL THE TIP OF THE AWL AND TO AVOID INJURY TO THE SURROUNDING SOFT TISSUES OR VESSELS. FOR THE DRIVER, THE TECHNIQUE GUIDE STATES USE THE GUIDING FORCEPS TO CONTROL THE SCREW WHILE INSERTING INTO OR REMOVING FROM THE AIMING DEVICE. THE PRIMARY PURPOSE OF THE U-JOINT MECHANISM ON THESE INSTRUMENTS IS TO ALLOW FOR THE TRANSMISSION OF TORQUE TO THE INSTRUMENT¿S WORKING END (DRIVER AND AWL) AT DIVERGENT ANGLES THE ACCESS EXPOSURE WOULD OTHERWISE NOT ACCOMMODATE FOR A STRAIGHT INSTRUMENT. AS THESE DEVICES WITH A LOSS OF POSITION RETENTION CAN STILL PERFORM THEIR PRIMARY FUNCTION OF TRANSMITTING TORQUE TO THE AWL TIP FOR PREPARING THE VERTEBRAL BODY CORTEX AND TRANSMITTING TORQUE TO THE DRIVER TIP FOR THE INSERTION OF SCREWS INTO THAT VERTEBRAL BODY, THE DESIGN IS ADEQUATE FOR THE APPLICATION WITH THE USE OF THE GUIDING FORCEPS AS SPECIFIED IN THE TECHNIQUE GUIDE. SYNFIX TRIAL: THE DESIGN OF THE TRIAL IMPLANT WAS REVIEWED AND FOUND TO BE APPROPRIATE FOR ITS INTENDED USE. THE FIRST TWO OR THREE INTERNAL THREADS TO THIS TRIAL IMPLANT HAVE BEEN STRIPPED, WITH THE THREAD MATERIAL MISSING FROM THE TRIAL. EVALUATION OF THE REMAINING THREADS SHOWS A TRANSITION ZONE BETWEEN THE STRIPPED AND INTACT SECTIONS WHERE THE THREADS ARE DEFORMED AND DISTORTED OFF THE INITIAL THREAD PATTERN, LEADING TO THE HYPOTHESIS THAT A TRIAL SPACER HANDLE (389.151) WAS CROSS-THREADED ONTO THIS SPACER. A POSITIVE ENGAGEMENT BETWEEN A CURRENT TRIAL SPACER HANDLE SPINDLE (03.802.151) AND THE REMAINING THREADS DEEPER WITHIN THE TRIAL WAS NOT POSSIBLE, CONFIRMING THAT THE THREADS HAVE BEEN DEFORMED OBSTRUCTING THE NORMAL THREAD PATH. HOWEVER, BASED ON THE COMPLAINT DESCRIPTION, IT IS DIFFICULT TO DETERMINE THE EXACT CAUSE OF THIS FAILURE MODE. PER THE TECHNIQUE GUIDE, THE TAPERED U-JOINT DRIVER (03.802.431) AND AWL (03.802.230) ARE TO BE USED WITH GUIDING FORCEPS (03.802.038) FOR POSITION GUIDANCE AND DIRECTIONAL CONTROL INTO AND OUT OF THE AIMING DEVICE DURING THE PROCEDURE. THE COMPLAINT ON THE DRIVERS AND AWL ARE DEEMED INVALID. THE FAILURE OF THE THREADS OF THE TRIAL SPACER ARE MOST LIKELY A RESULT OF CROSS THREADING OF THE TRIAL SPACER HANDLE TO THE DEVICE. HOWEVER, THE EXACT ROOT CAUSE FOR THE THREAD FAILURE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. THE COMPLAINT EVENT IS DEEMED INDETERMINATE. ORIGINAL AWARENESS DATE IS (B)(4) 2012. 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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION NOTED THE LOCKING THREAD WAS STRIPPED AT THE RUN-IN. DUE TO THE DAMAGE EXHIBITED IT CANNOT BE VERIFIED ANYMORE IF THE THREAD MET THE SPECIFICATIONS. THE DEVICE SHOWS WEAR AND WAS MANUFACTURED AND DISTRIBUTED IN MAY 2008, HENCE WE SUPPOSE THAT IT WAS IN FREQUENT USE AND MUST HAVE MET SPECIFICATIONS. DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING AN ALIF AT LEVELS L5-S1, WHILE TRYING TO INSERT THE TRIAL IMPLANT, THE BONE WAS VERY DENSE, AND BOTH U-JOINT DRIVERS AND A U-JOINT AWL LOST MEMORY AND WOULD NOT FUNCTION. IN ADDITION THE HANDLE OF THE TRIAL CAME OFF IN SITU. THE SURGEON USED ANOTHER SIZE TRIAL AND COMPLETED THE PROCEDURE. UPON EXAMINATION OF THE TRIAL IMPLANT FOLLOWING THE PROCEDURE, THE THREADS INSIDE THE TRIAL APPEARED TO BE STRIPPED. THIS IS 1 OF 4 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185417 SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 26MM/W 32MM/H 12MM HWT SYNTHES GMBH 2346511

    Patients

    Seq Age Sex Outcome Treatment
    1